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Food fortification (i.e., industrial fortification and biofortification) increases the micronutrient content of foods to improve population nutrition. Implementing effective fortification programs requires the generation and use of data to inform decision making. The use of digital tools and technologies (DTTs) for such purposes in broader nutrition programs is growing; however, there is limited consolidation of those used in fortification. This scoping review aimed to identify and describe DTTs used in fortification programs. We searched peer-reviewed and gray literature and conducted 17 stakeholder surveys. We then mapped DTTs identified against the fortification and nutrition data value chains. Of 11,741 articles identified, 158 met the inclusion criteria. From the included articles and stakeholder surveys, 125 DTTs were identified across three categories: software and tooling (n = 58), data and information lifecycle (n = 50), and hardware and infrastructure (n = 17). Gaps were identified in processing, post-harvest storage, aggregation, and transport nodes of the fortification value chain, and data prioritization, translation/dissemination, and decision-making nodes of the nutrition data value chain. DTTs have the potential to address challenges faced by fortification stakeholders to generate and use data to improve program decision making and nutritional impact. Further work is needed to standardize terminology, identify relevant DTTs from other sectors, and explore stakeholder needs., (© 2025 The Author(s). Annals of the New York Academy of Sciences published by Wiley Periodicals LLC on behalf of The New York Academy of Sciences.)

Biofortification - the process of increasing the concentrations of essential nutrients in staple crops - is a means of addressing the burden of micronutrient deficiencies at a population level via existing food systems, such as smallholder farms. To realise its potential for global impact, we need to understand the factors that are associated with decisions to adopt biofortified crops and food products. We searched the literature to identify adoption determinants, i.e. barriers to (factors negatively associated) or facilitators of (factors positively associated) adoption, of biofortified crops and food products. We found 41 studies reporting facilitator(s) and/or barrier(s) of adoption. We categorised the factors using the Consolidated Framework of Implementation Research 2.0, resulting in a set of factors that enable or constrain adoption of biofortified foods across twenty-four constructs and five domains of this meta-theoretical determinant framework from implementation science. Facilitators of orange sweet potato adoption included knowledge about importance, relative advantage, efficient production and management practices; barriers included lacking timely access to quality vines and market remoteness (28 studies total). Facilitators of vitamin A cassava adoption included awareness of its benefits and access to information; barriers included poor road networks and scarcity of improved technology including inadequate processing/storage facilities (8). Facilitators of high-iron bean adoption included farmers' networking and high farming experience; barriers included low knowledge of bean biofortification (8). Barriers to vitamin A maize adoption included low awareness and concerns regarding yield, texture and aflatoxin contamination (1). These barriers and facilitators may be a starting point for researchers to move towards testing implementation strategies and/or for policymakers to consider before planning scale-up and continuous optimisation of ongoing projects promoting adoption of biofortified crops and food products.

Background: Small-quantity lipid-based nutrient supplements (SQ-LNS), which has been widely tested to reduce child stunting, has largely modest effects to date, but the mechanisms underlying these modest effects are unclear. Child stunting is a longstanding indicator of chronic undernutrition and it remains a prevalent public health problem. The infant gut microbiome may be a key contributor to stunting; and mother and infant fucosyltransferase (FUT) phenotypes are important determinants of infant microbiome composition., Methods: We investigated whether mother-infant FUT status (n = 792) and infant gut microbiome composition (n = 354 fecal specimens from 172 infants) modified the impact of an infant and young child feeding (IYCF) intervention, that included SQ-LNS, on stunting at age 18 months in secondary analysis of a randomized trial in rural Zimbabwe., Findings: We found that the impact of the IYCF intervention on stunting was modified by: (i) mother-infant FUT2+/FUT3- phenotype (difference-in-differences -32.6% [95% CI: -55.3%, -9.9%]); (ii) changes in species composition that reflected microbiome maturation (difference-in-differences -68.1% [95% CI: -99.0%, -28.5%); and (iii) greater relative abundance of B. longum (differences-in-differences 49.1% [95% CI: 26.6%, 73.6%]). The dominant strains of B. longum when the intervention started were most similar to the proficient milk oligosaccharide utilizer subspecies infantis, which decreased with infant age and differed by mother-infant FUT2+/FUT3- phenotypes., Interpretation: These findings indicate that a persistently "younger" microbiome at initiation of the intervention reduced its benefits on stunting in areas with a high prevalence of growth restriction., Funding: Bill and Melinda Gates Foundation, UK DFID/Aid, Wellcome Trust, Swiss Agency for Development and Cooperation, US National Institutes of Health, UNICEF, and Nutricia Research Foundation., Competing Interests: Declaration of interests AJP was supported by Wellcome Trust grant 108065/Z/15/Z. ARM was supported by Bill & Melinda Gates Foundation grant OPP1021542 and OPP1143707, with a subcontract to the University of British Columbia 20R25498 EKG was supported by The Nutricia Research Foundation grant 2021-52. T.J.E. was paid a scientific consulting fee in relation to the analysis of the data presented here by the Zvitambo Institute for Maternal and Child Health Research. RCR declares remittance from Abbott Nutrition Health Institute and Nutricia for public conference talks outside of the submitted work in the past 36 months. All other authors declare that they have no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Context: It is important to understand the sensory acceptability of biofortified food products among target population groups if biofortification is to be realized as a sustainable strategy for mitigation of micronutrient deficiencies, able to be scaled up and applied through programs., Objective: This systemic review aims to summarize and synthesize the sensory acceptability of conventionally bred iron-, zinc-, and provitamin A-biofortified food products., Data Sources: MEDLINE (PubMed), AGRICOLA, AgEcon, CABI Abstracts (Web of Science), and organizational websites (eg, those of HarvestPlus and CGIAR and their partners) were searched for relevant articles. No access to any market research that may have been internally conducted for the commercial biofortified food products was available., Data Extraction: This review identified articles measuring the sensory acceptability of conventionally bred biofortified food products. Extraction of the hedonic ratings of food products was performed., Data Analysis: An "Acceptability Index %" was defined based on hedonic scoring to determine an overall rating, and used to categorize biofortified food products as "acceptable" (≥70%) or "not acceptable" (<70%). Additionally, this review narratively synthesized studies using methods other than hedonic scoring for assessing sensory acceptability., Conclusions: Forty-nine studies assessed the acceptability of 10 biofortified crops among children and adults, in mostly rural, low-income settings across Africa, Latin America, and India; food products made from mineral and provitamin A-biofortified food products were generally acceptable. Compared with studies on provitamin-A biofortified food products, few studies (1 to 2 each) on mineral-enhanced crops such as rice, cowpeas, lentils, and wheat were found, limiting the generalizability of the findings. Similarly, few studies examined stored biofortified food products. Few commercial food products have so far been developed, although new varieties of crops are being continuously tested and released globally. Certain crop varieties were found to be acceptable while others were not, suggesting that particular varieties should be prioritized for scale-up. Determining sensory acceptability of biofortified food products is important for informing programmatic scale-up and implementation across diverse populations and settings., (© The Author(s) 2023. Published by Oxford University Press on behalf of the International Life Sciences Institute.)

Child stunting is an indicator of chronic undernutrition and reduced human capital. However, it remains a poorly understood public health problem. Small-quantity lipid-based nutrient supplements (SQ-LNS) have been widely tested to reduce stunting, but have modest effects. The infant intestinal microbiome may contribute to stunting, and is partly shaped by mother and infant histo-blood group antigens (HBGA). We investigated whether mother-infant fucosyltransferase status, which governs HBGA, and the infant gut microbiome modified the impact of SQ-LNS on stunting at age 18 months among Zimbabwean infants in the SHINE Trial ( NCT01824940 ). We found that mother-infant fucosyltransferase discordance and Bifidobacterium longum reduced SQ-LNS efficacy. Infant age-related microbiome shifts in B. longum subspecies dominance from infantis , a proficient human milk oligosaccharide utilizer, to suis or longum , proficient plant-polysaccharide utilizers, were partly influenced by discordance in mother-infant FUT2+/FUT3- phenotype, suggesting that a "younger" microbiome at initiation of SQ-LNS reduces its benefits on stunting.

Background: Anemia poses a significant public health problem, affecting 1.6 billion people and contributing to the loss of 68.4 million disability-adjusted life years. We assessed the impact of a market-based home fortification program with micronutrient powder (MNP) called Pushtikona-5 implemented by Bangladesh Rural Advancement Committee (BRAC) on the prevalence of anemia among children aged 6-59 months in Bangladesh., Methods: We used a modified stepped wedged design and conducted three baseline, two midline, and three endline surveys to evaluate the Pushtikona-5 program implemented through three BRAC program platforms. We interviewed children's caregivers, and collected finger-prick blood samples from children to measure hemoglobin concentration. We also collected data on coverage of Pushtikona-5 and infant and young child feeding (IYCF) practices. We performed bivariate and multivariable analysis and calculated adjusted risk ratios (ARRs) to assess the effect of program outcomes., Results: A total of 16,936 households were surveyed. The prevalence of anemia was 46.6% at baseline, dropping to 32.1% at midline and 31.2% at endline. These represented adjusted relative reductions of 34% at midline (RR 0.66, 95%CI 0.62 to 0.71, value of p <0.001) and 32% at endline (RR 0.68, 95%CI 0.64 to 0.71, value of p <0.001) relative to baseline. Regarding MNP coverage, at baseline, 43.5% of caregivers surveyed had heard about MNP; 24.3% of children had ever consumed food with MNP, and only 1.8% had consumed three or more sachets in the 7 days preceding the survey. These increased to 63.0, 36.9, and 4.6%, respectively, at midline and 90.6, 68.9, and 11.5%, respectively, at endline., Conclusion: These results show evidence of a reduction in the prevalence of anemia and an improvement in coverage. This study provides important evidence of the feasibility and potential for impact of linking market-based MNP distribution with IYCF promotion through community level health workers., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Sarma, Rahman, Tariqujjaman, Islam, Mbuya, Aaron, Askari, Harbour, Khondker, Bipul, Sultana, Rahman, Shahin, Chowdhury, Afsana, Ghosh, Banwell, D’Este, Salasibew, Neufeld and Ahmed.)

Biofortification increases micronutrient content in staple crops through conventional breeding, agronomic methods, or genetic engineering. Bioaccessibility is a prerequisite for a nutrient to fulfill a biological function, e.g., to be bioavailable. The objective of this systematic review is to examine the bioavailability (and bioaccessibility as a proxy via in vitro and animal models) of the target micronutrients enriched in conventionally biofortified crops that have undergone post-harvest storage and/or processing, which has not been systematically reviewed previously, to our knowledge. We searched for articles indexed in MEDLINE, Agricola, AgEcon, and Center for Agriculture and Biosciences International databases, organizational websites, and hand-searched studies' reference lists to identify 18 studies reporting on bioaccessibility and 58 studies on bioavailability. Conventionally bred biofortified crops overall had higher bioaccessibility and bioavailability than their conventional counterparts, which generally provide more absorbed micronutrient on a fixed ration basis. However, these estimates depended on exact cultivar, processing method, context (crop measured alone or as part of a composite meal), and experimental method used. Measuring bioaccessibility and bioavailability of target micronutrients in biofortified and conventional foods is critical to optimize nutrient availability and absorption, ultimately to improve programs targeting micronutrient deficiency.

Post-harvest handling can affect micronutrient retention in biofortified crops through to the point of consumption. Here we conduct a systematic review identifying 67 articles examining the retention of micronutrients in conventionally bred biofortified maize, orange sweet potato, cassava, pearl millet, rice, beans and wheat. Provitamin A crops maintain high amounts compared with non-biofortified counterparts. Iron and zinc crops have more variability in micronutrient retention dependent on processing method; for maximum iron and zinc content, whole grain product consumption such as whole wheat flour or only slightly milled brown rice is beneficial. We offer preliminary suggestions for households, regulatory bodies and programme implementers to increase consumer awareness on best practices for preparing crops to maximize micronutrient content, while highlighting gaps in the literature. Our online, interactive Micronutrient Retention Dashboard ( https://www.cpnh.cornell.edu/mn-retention-db ) offers an at-a-glance view of the compiled minimum and maximum retention found, organized by processing method., (© 2023. The Author(s).)

Information on fortifiable food consumption is essential to design, monitor and evaluate fortification programmes, yet detailed methods like 24-h recalls (24HRs) that provide such data are rarely conducted. Simplified questionnaire-based methods exist but their validity compared with 24HRs has not been shown. We compared two simplified methods (i.e., a household food acquisition and purchase questionnaire [FAPQ] and a 7-day semiquantitative food frequency questionnaire [SQ-FFQ]) against 24HRs for estimating fortifiable food consumption. We assessed the consumption of fortifiable wheat flour and oil using a FAPQ and, for wheat flour only, a 7-day SQ-FFQ and compared the results against 24HRs. The participants included children 12-18 months (n = 123) and their mothers 18-49 years selected for a study assessing child vitamin A intake and status in Mandaluyong City, Philippines. For fortifiable wheat flour, the FAPQ estimated considerably lower mean intakes compared to 24HRs for children and mothers (2.2 vs. 14.1 g/day and 5.1 vs. 42.3 g/day, respectively), while the SQ-FFQ estimated slightly higher mean intakes (15.7 vs. 14.1 g/day and 51.5 vs. 42.3 g/day, respectively). For fortifiable oil, the FAPQ estimated considerably higher mean intakes compared to 24HRs for children and mothers (4.6 vs. 1.8 g/day and 12.5 vs. 6.1 g/day, respectively). The SQ-FFQ, but not the FAPQ, generated useful information on fortifiable food consumption that can inform fortification programme design and monitoring decisions in the absence of more detailed individual-level data. Potential adaptations to improve the FAPQ, such as additional questions on foods prepared away from home and usage patterns, merit further research., (© 2023 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.)

Background: Inadequate food and water resources negatively affect child health and the efficiency of nutrition interventions., Methods: We used data from the SHINE trial to investigate the associations of food insecurity (FI) and water insecurity (WI) on mothers' implementation and maintenance of minimum infant dietary diversity (MIDD). We conducted factor analysis to identify and score dimensions of FI (poor access, household shocks, low availability & quality), and WI (poor access, poor quality and low reliability). MIDD implementation (n = 636) was adequate if infants aged 12 months (M12) ate ≥ four food groups. MIDD maintenance (n = 624) was categorized into four mutually exclusive groups: A (unmet MIDD at both M12 and M18), B (unmet MIDD at M12 only), C (unmet MIDD at M18 only), and D (met MIDD at both M12 and M18). We used multivariable-adjusted binary logistic and multinomial regressions to determine likelihood of MIDD implementation, and of belonging to MIDD maintenance groups A-C (poor maintenance groups), compared to group D, respectively., Results: Low food availability & quality were negatively associated with implementation (OR = 0.81; 0.69, 0.97), and maintenance (OR B  = 1.29; 1.07, 1.56). Poor water quality was positively associated with implementation (OR = 1.25; 1.08, 1.44), but inconsistently associated with maintenance, with higher odds of infants being in group C (OR = 1.39; 1.08, 1.79), and lower odds of being in group B (OR = 0.80; 0.66, 0.96)., Conclusion: Food security should be prioritized for adequate implementation and maintenance of infant diets during complementary feeding. The inconsistent findings with water quality indicate the need for further research on WI and infant feeding., (© 2022. The Author(s).)

Background: Micronutrient deficiencies compromise immune systems, hinder child growth and development, and affect human potential worldwide. Yet, to our knowledge, the only existing estimate of the global prevalence of micronutrient deficiencies is from over 30 years ago and is based only on the prevalence of anaemia. We aimed to estimate the global and regional prevalence of deficiency in at least one of three micronutrients among preschool-aged children (aged 6-59 months) and non-pregnant women of reproductive age (aged 15-49 years)., Methods: In this pooled analysis, we reanalysed individual-level biomarker data for micronutrient status from nationally representative, population-based surveys. We used Bayesian hierarchical logistic regression to estimate the prevalence of deficiency in at least one of three micronutrients for preschool-aged children (iron, zinc, and vitamin A) and for non-pregnant women of reproductive age (iron, zinc, and folate), globally and in seven regions using 24 nationally representative surveys done between 2003 and 2019., Findings: We estimated the global prevalence of deficiency in at least one of three micronutrients to be 56% (95% uncertainty interval [UI] 48-64) among preschool-aged children, and 69% (59-78) among non-pregnant women of reproductive age, equivalent to 372 million (95% UI 319-425) preschool-aged children and 1·2 billion (1·0-1·4) non-pregnant women of reproductive age. Regionally, three-quarters of preschool-aged children with micronutrient deficiencies live in south Asia (99 million, 95% UI 80-118), sub-Saharan Africa (98 million, 83-113), or east Asia and the Pacific (85 million, 61-110). Over half (57%) of non-pregnant women of reproductive age with micronutrient deficiencies live in east Asia and the Pacific (384 million, 279-470) or south Asia (307 million, 255-351)., Interpretation: We estimate that over half of preschool-aged children and two-thirds of non-pregnant women of reproductive age worldwide have micronutrient deficiencies. However, estimates are uncertain due to the scarcity of population-based micronutrient deficiency data., Funding: US Agency for International Development., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

The lack of nationally representative, individual-level dietary intake data has led researchers to increasingly turn to household-level data on food acquisitions and/or consumption to inform the design of food-fortification programs in low- and middle-income countries (LMICs). These nationally representative, household-level data come from household consumption and expenditure surveys (HCESs), which are collected regularly in many LMICs and are often made publicly available. Our objectives were to examine the utility of HCES data to inform the design of food-fortification programs and to identify best-practice methods for analyzing HCES data for this purpose. To this end, we summarized information needed to design fortification programs and assessed the extent to which HCES data can provide corresponding indicators. We concluded that HCES data are well suited to guide the selection of appropriate food vehicles, but because individual-level estimates of apparent nutrient intakes rely on assumptions about the intrahousehold distribution of food, more caution is advised when using HCES data to select the target micronutrient content of fortified foods. We also developed a checklist to guide analysts through the use of HCES data and, where possible, identified research-based, best-practice analytical methods for analyzing HCES data, including selecting the number of days of recall data to include in the analysis and converting reported units to standard units. More research is needed on how best to deal with composite foods, foods consumed away from home, and extreme values, as well as the best methods for assessing the adequacy of apparent intakes. Ultimately, we recommend sensitivity analyses around key model parameters, and the continual triangulation of HCES-based results with other national and subnational data on food availability, dietary intake, and nutritional status when designing food-fortification programs., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Introduction: Multiple micronutrient supplementation (MMS) during pregnancy has a greater potential for reducing the risk of low birth weight (LBW) compared with the standard iron-folic acid supplementation. WHO recently included MMS on their Essential Medicines List. The Social Marketing Company (SMC) in Bangladesh is implementing a countrywide, market-based roll-out of MMS to pregnant women. We aimed to evaluate the implementation of the supplementation programme and its impact on reducing LBW., Methods and Analysis: A two-arm, quasi-experimental and mixed-methods evaluation design will be used to evaluate the impact of this 36-month roll-out of MMS. In the intervention areas, pregnant women will purchase MMS products from the SMC's pharmacy networks. Pregnant women in comparison areas will not be exposed to this product until the end of the study. We will collect 4500 pregnant women's data on anthropometric, socioeconomic, nutrition-related and relevant programme indicators during recruitment and bimonthly follow-up until the end of their pregnancy. We will measure children's birth weight within 72 hours of birth and evaluate the changes in LBW prevalence. We will observe market-based MMS service delivery-related conditions of the pharmacies and the quality of the provider's service delivery. Concurrently, we will carry out a process evaluation to appraise the programme activities and recommend course correction. Cluster-adjusted multivariable logistic regression or log-binomial regression analysis of quantitative outcome data will be performed. For qualitative data, we will follow a thematic analysis approach. We will consolidate our study findings by triangulating the data derived from different methods., Ethics and Dissemination: This study received ethical approval from the institutional review board of icddr,b (PR number 21001). We will recruit eligible participants after obtaining their informed written/verbal consent (and assent where needed) with full disclosure about the study. The results will be disseminated through peer-reviewed publications and conference presentations., Trial Registration Number: NCT05108454., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Vitamin A (VA) deficiency continues to be a major global health issue, despite measures to increase VA intake via consumption of staple foods such as edible oil. Portable quantitative and semiquantitative devices or test kits for internal quality control have the potential to overcome some of the limitations of traditional methods of testing, such as centralized laboratory, expensive equipment, and specially trained staff. This landscape analysis and comprehensive systematic mini-review catalogs and summarizes evidence on the analytical performance of portable quantitative and semiquantitative devices and test kits for the analysis of VA in edible oil. Studies or reports detailing the usability and validation of portable devices and/or test kits, as well as studies comparing device/test kit performance to a reference standard such as high-performance liquid chromatography (HPLC), were included. Identified devices and test kits were compared for performance versus the reference standard, usability, availability, and other characteristics. We identified four portable methods: two devices, the iCheck CHROMA and iCheck Chroma 3 from BioAnalyt; and two test kits, the QuickView from Bagco Enterprises and the Strategic Alliance for the Fortification of Vegetable Oils (SAFO) Test Kit by Badische Anilin and Soda Fabrik (BASF). Included studies reported the following: an internal validation of the portable method, a comparison of the portable method against a reference standard, a comparison of the portable method against another portable method, and several videos and company websites, which detailed device characteristics. iCheck CHROMA and QuickView quantified VA concentrations with high accuracy and precision compared to the reference standard for field-based quantification, were user-friendly, and provided results within 5 min. iCheck Chroma 3 requires more robust validation against a reference standard. We did not find data on internal validation or comparison against a reference standard for the current version of the SAFO test. Compared to QuickView and SAFO, the iCheck devices can transfer results to a hard drive or the Web, have an online order form for purchase, and meet a minimal set of criteria for point-of-need devices. iCheck, QuickView, and SAFO can quantify VA concentrations in the edible oils tested and determine whether a fortified oil meets country standards. Additional research is needed to validate these devices and test kits across additional oil types and document the ability to meet the minimal criteria for point-of-need devices suggested in this mini-review. Validation against a reference standard is required for SAFO. The limited number of portable methods available may be due to market saturation. Future market and use case analyses to inform the market size and utility of the different tests with publicly available data will allow new manufacturers, particularly those in lower-to-middle-income countries, to enter the market., Competing Interests: The authors declare the following competing financial interest(s): SM is an unpaid board member for a diagnostic start-up focused on developing point-of-care assays for nutritional status informed by his research as a faculty member at Cornell University. All other authors have no competing interests to declare., (© 2022 The Authors. Published by American Chemical Society.)

Background: We catalog and summarize evidence of the analytical performance of portable quantitative and semi-quantitative devices for the assessment of vitamin A status and vitamin A deficiency (VAD) in various biological samples-including whole blood, plasma, serum, and milk-in addition to VAD determination by functional indicators such as pupillary response., Methods: We searched the literature for published research articles, patents, and information from manufacturers of mobile devices, particularly those appropriate for low-resource settings. The included devices were required to be portable (lightweight and ideally not needing a power outlet) and to measure vitamin A as well as define VAD. Eligible studies compared a portable device to a reference standard of high-performance liquid chromatography for blood and milk, or a Goldmann-Weekers dark adaptometer for eyes/vision. Where available, identified devices were compared with reference methods across several performance criteria. When possible, we compared the device's performance reported in published studies against the stated performance criteria from the manufacturers' websites., Results: We catalogued 25 portable devices for measuring vitamin A and/or VAD via biological samples. We also identified 18 comparison studies (plus associated reports) assessing nine methods: the iCheck Fluoro, iCheck Carotene, CRAFTi, Tidbit with or without the HYPER filtration system, custom field-friendly immunoassays, and microfluidic assays for blood; the iCheck Fluoro and iCheck Carotene for milk; and the Scotopic Sensitivity Tester-1 for eye function., Conclusions: The iCheck Fluoro and iCheck Carotene are commercially available for use and are acceptable for measuring vitamin A in blood and milk samples, according to the available validation data. Many of the other identified devices, including other portable fluorometers, photometers, immunoassays, microfluidics-based devices, and dark adaptometers, were proofs of concept and not yet commercially available. Furthermore, none of these other devices included manufacturer-described device performance criteria to compare with descriptions from experimental studies. Several gaps remain, including studies comparing the other portable devices against a reference standard, particularly for functional indicators of vitamin A status/deficiency; available manufacturer-reported device performance criteria against which to compare future results of investigations; and more comprehensive reporting of validation metrics including sensitivity, specificity, precision, and Bland-Altman analysis., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Author(s).)

Biofortification is the process of increasing the concentrations and/or bioavailability of micronutrients in staple crops and has the potential to mitigate micronutrient deficiencies globally. Efficacy trials have demonstrated benefits of consuming biofortified crops (BFCs); and in this paper, we report on the results of a systematic review of biofortified crops effectiveness in real-world settings. We synthesized the evidence on biofortified crops consumption through four Impact Pathways: (1) purchased directly; (2) in informal settings; (3) in formal settings; or (4) in farmer households, from their own production. Twenty-five studies, covering Impact Pathway 1 (five studies), Impact Pathway 2 (three), Impact Pathway 3 (three), Impact Pathway 4 (21) were included. The review found evidence of an improvement in micronutrient status via Impact Pathway 4 (mainly in terms of vitamin A from orange sweet potato) in controlled interventions that involved the creation of demand, the extension of agriculture and promotion of marketing. In summary, evidence supports that biofortified crops can be part of food systems interventions to reduce micronutrient deficiencies in farmer households; ongoing and future research will help fully inform their potential along the other three Impact Pathways for scaling up.

Background: Although the potential impact of food fortification to improve the micronutrient status of populations has been demonstrated beyond a doubt, it is constrained in practice by critical gaps in program design and implementation. These are partly linked to suboptimal decision making., Objectives: We aimed to demonstrate how the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Evidence to Decision (EtD) framework for health system and public health decisions can be applied to formulate recommendations and make decisions in national food fortification programming., Methods: Following a program impact pathway, we reviewed the literature to define the key decision types and identify the corresponding decision makers necessary for designing and implementing effective food fortification programs. We then applied the GRADE EtD framework to the Nigerian fortification program to illustrate how evidence-informed assessments and conclusions can be made., Results: Fortification program decisions were classified into 5 types: 1 ) program initiation; 2 ) program design; 3 ) program delivery; 4 ) program impact; and 5 ) program continuation. Policymakers, food processors, and (in cases dependent on or considering external funding) development partners are the main decision makers in a fortification program, whereas technical partners play important roles in translating evidence into contextualized recommendations. The availability and certainty of evidence for fortification programs are often low (e.g., quality and coverage data are not routinely collected and there are challenges evaluating impact in such population-based programs using randomized controlled trials) yet decisions must still be made, underscoring the importance of using available evidence. Furthermore, when making program initiation and continuation decisions, coordination with overlapping micronutrient interventions is needed where they coexist., Conclusions: This framework is a practical tool to strengthen decision-making processes in fortification programs. Using evidence in a systematic and transparent way for decision making can improve fortification program design, delivery, and ultimately health impacts., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Double fortified salt (DFS) has proven efficacy in addressing iron deficiency and anaemia, thus improving maternal and child nutrition outcomes. However, DFS delivery in large-scale settings is less understood, with limited documentation of its fidelity of implementation (FOI). We assessed the FOI of the DFS intervention in Uttar Pradesh, India, to improve the design and implementation of such programmes that aim to reduce the anaemia burden, especially in women of reproductive age (WRA). We conducted in-depth interviews with DFS programme staff (n = 25) and end-user WRAs (23), guided by a programme impact pathway. We transcribed and thematically analysed the interviews and used an adapted analytic framework to document FOI across four domains-objects of intervention, implementation staff, implementation context and target of implementation. DFS utilisation remained low due to a combination of factors including poor product quality, distribution challenges, ineffective promotion and low awareness amongst end-user WRAs. Motivation levels were higher amongst district-level staff compared to frontline staff, who lacked supervisory support and effective incentives to promote DFS. Three typologies of DFS users emerged-'believers', 'thrifters' and 'naysayers'-who indicated differing reasons for DFS purchase and its use or nonuse. The implementation of the DFS programme varied significantly from its theorised programme impact pathway. The adapted analytic framework helped document FOI and assess the programme's readiness for impact assessments and subsequent scale-up. The programme needs product quality improvements, incentivised distribution and stronger promotion to effectively deliver and improve the realisation of its potential as an anaemia prevention strategy., (© 2021 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.)

Background: Meta-analyses show that small-quantity lipid-based nutrient supplements (SQ-LNSs) reduce child stunting and wasting. Identification of subgroups who benefit most from SQ-LNSs may facilitate program design., Objectives: We aimed to identify study-level and individual-level modifiers of the effect of SQ-LNSs on child growth outcomes., Methods: We conducted a 2-stage meta-analysis of individual participant data from 14 randomized controlled trials of SQ-LNSs provided to children 6-24 mo of age (n = 37,066). We generated study-specific and subgroup estimates of SQ-LNS compared with control and pooled the estimates using fixed-effects models. We used random-effects meta-regression to examine study-level effect modifiers. In sensitivity analyses, we examined whether results differed depending on study arm inclusion criteria and types of comparisons., Results: SQ-LNS provision decreased stunting (length-for-age z score < -2) by 12% (relative reduction), wasting [weight-for-length (WLZ) z score < -2] by 14%, low midupper arm circumference (MUAC) (<125 mm or MUAC-for-age z score < -2) by 18%, acute malnutrition (WLZ < -2 or MUAC < 125 mm) by 14%, underweight (weight-for-age z score < -2) by 13%, and small head size (head circumference-for-age z score < -2) by 9%. Effects of SQ-LNSs generally did not differ by study-level characteristics including region, stunting burden, malaria prevalence, sanitation, water quality, duration of supplementation, frequency of contact, or average compliance with SQ-LNS. Effects of SQ-LNSs on stunting, wasting, low MUAC, and small head size were greater among girls than among boys; effects on stunting, underweight, and low MUAC were greater among later-born (than among firstborn) children; and effects on wasting and acute malnutrition were greater among children in households with improved (as opposed to unimproved) sanitation., Conclusions: The positive impact of SQ-LNSs on growth is apparent across a variety of study-level contexts. Policy-makers and program planners should consider including SQ-LNSs in packages of interventions to prevent both stunting and wasting.This trial was registered at www.crd.york.ac.uk/PROSPERO as CRD42019146592., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Background: Small-quantity lipid-based nutrient supplements (SQ-LNSs) have been shown to reduce the prevalence of child anemia and iron deficiency, but effects on other micronutrients are less well known. Identifying subgroups who benefit most from SQ-LNSs could support improved program design., Objectives: We aimed to identify study-level and individual-level modifiers of the effect of SQ-LNSs on child hemoglobin (Hb), anemia, and inflammation-adjusted micronutrient status outcomes., Methods: We conducted a 2-stage meta-analysis of individual participant data from 13 randomized controlled trials of SQ-LNSs provided to children 6-24 mo of age (n = 15,946). We generated study-specific and subgroup estimates of SQ-LNSs compared with control, and pooled the estimates using fixed-effects models. We used random-effects meta-regression to examine potential study-level effect modifiers., Results: SQ-LNS provision decreased the prevalence of anemia (Hb < 110 g/L) by 16% (relative reduction), iron deficiency (plasma ferritin < 12 µg/L) by 56%, and iron deficiency anemia (IDA; Hb < 110 g/L and plasma ferritin <12 µg/L) by 64%. We observed positive effects of SQ-LNSs on hematological and iron status outcomes within all subgroups of the study- and individual-level effect modifiers, but effects were larger in certain subgroups. For example, effects of SQ-LNSs on anemia and iron status were greater in trials that provided SQ-LNSs for >12 mo and provided 9 (as opposed to <9) mg Fe/d, and among later-born (than among first-born) children. There was no effect of SQ-LNSs on plasma zinc or retinol, but there was a 7% increase in plasma retinol-binding protein (RBP) and a 56% reduction in vitamin A deficiency (RBP < 0.70 µmol/L), with little evidence of effect modification by individual-level characteristics., Conclusions: SQ-LNSs can substantially reduce the prevalence of anemia, iron deficiency, and IDA among children across a range of individual, population, and study design characteristics. Policy-makers and program planners should consider SQ-LNSs within intervention packages to prevent anemia and iron deficiency.This trial was registered at www.crd.york.ac.uk/PROSPERO as CRD42020156663., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Micronutrient deficiency is a pertinent global challenge that affects billions of people and has deleterious health effects. Large-scale food fortification (LSFF) is a cost- effective way to tackle micronutrient deficiency and improve health outcomes, particularly in low- and middle-income countries (LMICs). However, the success of LSFF in LMICs is often hampered by limited compliance with fortification mandates by the private sector, who supply fortified foods. In this paper, we use a case study of the edible oil produced in Bangladesh to analyze the factors facilitating and impeding this compliance by for-profit actors. We identified four bottlenecks that disincentivize private sector actors' decision to comply. First, fortified and non-fortified products co-exist in the market, disincentivizing producers to invest in fortification. Second, the lack of traceability reduces the risk for large-scale producers' non-compliance with the regulation. Third, small-scale producers face economic pressures that prevent them from adequately fortifying oil products. Lastly, law enforcement is currently inconsistent, allowing the supply of under-fortified oil in the market. Given the evidence, we recommend to strengthen the control of bulk item fortification through more frequent and rigorous surveillance at the production level. This will ensure that resource constrained consumers who also have the greatest potential to benefit from added nutrients, remain able to access affordable and nutrient-enriched food., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 The Author(s).)

Seventeen per cent of the world's population is estimated to be at risk of inadequate zinc intake, which could in part be addressed by zinc fortification of widely consumed foods. We conducted a review of efficacy and effectiveness studies to ascertain the effect of zinc fortification [postharvest fortification of an industrially produced food or beverage; alone or with multiple micronutrients (MMN)] on a range of health outcomes. Previous reviews have required that the effect of zinc be isolated; because zinc is always cofortified with MMN in existing fortification programs, we did not impose this condition. Outcomes assessed were zinc-related biomarkers (plasma or serum, hair or urine zinc concentrations, comet assay, plasma fatty acid concentrations, and the proportion of and total zinc absorbed in the intestine from the diet), child anthropometry, morbidity, mortality, cognition, plasma or serum iron and copper concentrations, and for observational studies, a change in consumption of the food vehicle. Fifty-nine studies were included in the review; 54 in meta-analyses, totaling 73 comparisons. Zinc fortification with and without MMN increased plasma zinc concentrations (efficacy, n = 27: 4.68 μg/dL; 95% CI: 2.62-6.75; effectiveness, n = 13: 6.28 μg/dL; 95% CI: 5.03-7.77 μg/dL) and reduced the prevalence of zinc deficiency (efficacy, n = 11: OR: 0.76, 95% CI: 0.60-0.96; effectiveness, n = 10: OR: 0.45, 95% CI: 0.31-0.64). There were statistically significant increases in child weight (efficacy, n = 11: 0.43 kg, 95% CI: 0.11-0.75 kg), improvements in short-term auditory memory (efficacy, n = 3: 0.32 point, 95% CI: 0.13-0.50 point), and decreased incidence of diarrhea (efficacy, n = 3: RR: 0.79, 95% CI: 0.68-0.92) and fever (efficacy, n = 2: RR: 0.85, 95% CI: 0.74-0.97). However, these effects cannot be solely attributed to zinc. Our review found that zinc fortification with or without MMN reduced the prevalence of zinc deficiency and may provide health and functional benefits, including a reduced incidence of diarrhea., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Impact of national food fortification programs is contingent on the extent to which there is compliance with national standards. However, this compliance is often sub-optimal and is not consistently measured. One of the challenges to more regular measurement is an over-reliance on quantitative assessments of micronutrient levels for compliance, which are costly. In resource constrained environments, this contributes to weaknesses in regulatory monitoring. We offer an alternative, systems-based approach to determine compliance, presenting a unique score that can capture firms' compliance behaviour, based on whether and how firms actually carry out stages of the fortification process. The key utility of such a measure being its use to monitor fortification propensity and assess changes in response to interventions. Further, we present an empirical application of this measure, providing novel evidence on firms' compliance towards food fortification regulations in Bangladesh, investigating the institutional and firm-level factors that correlate with compliance behaviour towards food fortification regulations among edible oil and salt producers., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 The Author(s).)

Adequate zinc nutrition is important for child growth, neurodevelopment, immune function, and normal pregnancy outcomes. Seventeen percent of the global population is estimated to be at risk for inadequate zinc intake. However, zinc is not included in the fortification standards of several low- and middle-income countries with mandatory fortification programs, despite data suggesting a zinc deficiency public health problem. To guide policy decisions, we investigated the factors enabling and impeding the inclusion of zinc as a fortificant by conducting in-depth interviews with 17 key informants from 10 countries. Findings revealed the decision to include zinc was influenced by guidance from international development partners and enabled by the assessment of zinc deficiency, mandatory regional food fortification standards which included zinc, the World Health Organization (WHO) guidelines for zinc fortification, and the low cost of zinc compound commonly used. Barriers included the absence of zinc from regional fortification standards, limited available data on the efficacy and effectiveness of zinc fortification, and the absence of national objectives related to the prevention of zinc deficiency. To promote zinc fortification there is a need to put the prevention of zinc deficiency higher on the international nutrition agenda and to promote large-scale food fortification as a key deficiency mitigation strategy.

Background : With millions of people experiencing malnutrition and inadequate water access, FI and WI remain topics of vital importance to global health. Existing unidimensional FI and WI metrics do not all capture similar multidimensional aspects, thus restricting our ability to assess and address food- and water-related issues. Methods : Using the Sanitation, Hygiene and Infant Nutrition Efficacy (SHINE) trial data, our study conceptualizes household FI ( N = 3551) and WI ( N = 3311) separately in a way that captures their key dimensions. We developed measures of FI and WI for rural Zimbabwean households based on multiple correspondence analysis (MCA) for categorical data. Results : Three FI dimensions were retained: 'poor food access', 'household shocks' and 'low food quality and availability', as were three WI dimensions: 'poor water access', 'poor water quality', and 'low water reliability'. Internal validity of the multidimensional models was assessed using confirmatory factor analysis (CFA) with test samples at baseline and 18 months. The dimension scores were associated with a group of exogenous variables (SES, HIV-status, season, depression, perceived health, food aid, water collection), additionally indicating predictive, convergent and discriminant validities. Conclusions : FI and WI dimensions are sufficiently distinct to be characterized via separate indicators. These indicators are critical for identifying specific problematic insecurity aspects and for finding new targets to improve health and nutrition interventions.

Background: Child stunting remains a poorly understood, prevalent public health problem. Environmental enteric dysfunction (EED) is hypothesized to be an important underlying cause., Objectives: Within a subgroup of 1169 children enrolled in the SHINE (Sanitation Hygiene Infant Nutrition Efficacy) trial in rural Zimbabwe, followed longitudinally from birth to 18 mo of age, we evaluated associations between the concentration of 11 EED biomarkers and linear growth velocity., Methods: At infant ages 1, 3, 6, 12, and 18 mo, nurses measured child length and collected stool and blood; the lactulose-mannitol urine test was also conducted at all visits except at 1 mo. Stool neopterin, α-1 antitrypsin, myeloperoxidase, and regenerating gene 1β protein; urinary lactulose and mannitol; and plasma kynurenine, tryptophan, C-reactive protein, insulin-like growth factor-1 (IGF-1), soluble CD14, intestinal fatty acid binding protein, and citrulline were measured. We analyzed the change in relative [∆ length-for-age z score (LAZ)/mo] and absolute (∆ length/mo) growth velocity during 4 age intervals (1-3 mo; 3-6 mo; 6-12 mo; and 12-18 mo) per SD increase in biomarker concentration at the start of each age interval., Results: In fully adjusted models, we observed only 3 small, statistically significant associations: kynurenine:tryptophan ratio at 12 mo was associated with decreased mean LAZ velocity during the 12-18 mo interval (-0.015 LAZ/mo; 95% CI: -0.029, -0.001 LAZ/mo); mannitol excretion at 6 mo was associated with increased LAZ velocity during the 6-12 mo interval (0.013 LAZ/mo; 95% CI: 0.001, 0.025 LAZ/mo), and plasma IGF-1 at 1 mo was associated with increased LAZ velocity during the 1-3 mo interval (0.118 LAZ/mo; 95% CI: 0.024, 0.211 LAZ/mo). Results for absolute growth velocity were similar, except IGF-1 was also associated with growth during the 12-18 mo interval. We found no other associations between any EED biomarker and linear growth velocity., Conclusions: None of 11 biomarkers of EED were consistently associated with linear growth among Zimbabwean children.This trial was registered at clinicaltrials.gov as NCT01824940., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Between birth and 2 years, children's well-being depends on the quality of care they receive from caregivers, primarily their mothers. We developed a quantitative survey instrument to assess seven psychosocial characteristics of women that determine their caregiving ability ('maternal capabilities': physical health, mental health, decision-making autonomy, social support, mothering self-efficacy, workload and time stress, and gender norm attitudes). We measured maternal capabilities in 4,025 mothers and growth in their 4,073 children participating in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe. We used generalized estimating equation models with exchangeable correlation structure to test the association between each maternal capability during pregnancy, and infant length-for-age Z (LAZ) at 18 months, accounting only for within-cluster correlation and intervention arms in unadjusted analyses and for potential confounders in adjusted analyses to examine the association between each capability, assessed during pregnancy, with child LAZ at 18 months of age. In adjusted models, each unit increase in gender norm attitudes score (reflecting more equitable gender norm attitudes) was associated with +0.09 LAZ (95% CI: 0.02, 0.16) and a decreased odds of stunting (adjusted odds ratio [AOR]: 0.86; 95% CI: 0.74, 1.01); each unit increase in social support score was associated with +0.11 LAZ (95% CI: 0.05, 0.17, p < 0.010) and decreased odds of stunting (AOR: 0.83; 95% CI: 0.73, 0.96). Each unit increase in decision-making autonomy was associated with a 6% reduced odds of stunting (AOR: 0.94; 95% CI: 0.89, 0.996, p = 0.04). Interventions and social programming that strengthen these maternal capabilities may improve child nutritional status., (© 2020 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.)

Background: Double-fortified salt (DFS) with iron and iodine has been demonstrated to be efficacious but questions of unintended effects on the gains in salt iodization remain. The main cross-sectional study based on the use of DFS over 1 y showed a reduction in iron deficiency risk. Whether the programs and the levels of added iron can adversely affect iodine status is yet to be established., Objectives: We hypothesized that the addition of iron to iodized salt can adversely affect iodine status in women of reproductive age (WRA)., Methods: A cross-sectional substudy was conducted in 4 matched-pair adjacent districts of rural Uttar Pradesh, India, in 2019. Under the public distribution system (PDS), DFS was available for 1 y through Fair Price Shops, in the 2 DFS supply districts (DFS-SDs). In these districts, iodized salt was also available in the market. In the 2 compared DFS nonsupply districts (DFS-NSDs), only iodized salt was available. In the substudy, participants included WRA ( n  = 1624) residing in rural areas of the selected districts. Iodine content in urine and salt samples was measured in each of the groups., Results: Significantly fewer women from the DFS-SDs had median urinary iodine concentration values indicative of moderate to mild iodine deficiency compared with the women from the DFS-NSDs. The salt purchase pattern and iodine content revealed that significantly fewer (21.99%) households in the DFS-SDs were purchasing inadequately iodized crystal salt, compared with 36.04% households in the DFS-NSDs., Conclusions: The data reject the working hypothesis and suggest a beneficial effect of the DFS program on the iodine status in WRA, thereby supporting a recommendation of DFS supply through the PDS., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Background: Food systems are increasingly recognized as critical for advancing nutrition, and the food environment is viewed as the nexus between those systems and dietary consumption. Developing a measurement framework of the market food environment is a research priority, particularly for low- and middle-income countries (LMICs), which face rapid shifts in markets, dietary patterns, and nutrition outcomes., Objectives: In this study, we sought to assess current conceptions and measures of the market food environment that could be adapted for use in LMICs., Methods: We conducted a narrative review of the literature to identify measures of the market food environment in recent use. First, we identified and reviewed frameworks of the food environment for LMICs with a specific focus on the market food environment. Second, we compiled 141 unique measures of the market food environment from 20 articles into a list that was pile-sorted by 5 nutrition experts into domains. We then categorized the measures based on percentage agreement across all sorts. Finally, we compared measured and conceptual domains of the market food environment to identify measurement gaps and needed adaptations., Results: Conceptual frameworks provide differing definitions of the market food environment but conform in their definitions of food availability, price, marketing, and product characteristics. Greater clarity is needed in defining relevant vendor and product characteristics. Eight measured domains of the market food environment emerged from the literature review, with significant overlap among conceptual domains. Measurement gaps exist for food quality, safety, packaging, desirability, and convenience. Personal characteristics also emerged as measured domains, although these are not part of the food environment per se., Conclusions: These results are a step toward elucidating how, why, and where we measure the market food environment in LMICs. Future research should focus on prioritizing the most meaningful methods and metrics and on developing new measures where gaps exist., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Background: Young children require high-quality care for healthy growth and development. We defined "maternal capabilities" as factors that influence mothers' caregiving ability (physical and mental health, social support, time, decision-making autonomy, gender norm attitudes, and mothering self-efficacy), and developed survey tools to assess them., Objectives: We hypothesized that mothers with stronger capabilities during pregnancy would be more likely to practice improved care behaviors after their child was born., Methods: We assessed maternal capabilities among 4667 pregnant women newly enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial. Several improved child-care practices were promoted until 18 mo postpartum, the trial endpoint. Care practices were assessed by survey, direct observation, or transcription from health records during postpartum research visits. We used logistic regression to determine the predictive association between maternal capabilities during pregnancy and child-care practices., Results: Mothers with more egalitarian gender norm attitudes were more likely to have an institutional delivery [adjusted OR (AOR), 2.06; 95% CI, 1.57-2.69], initiate breastfeeding within 1 h of delivery (AOR, 1.38; 95% CI, 1.03-1.84), exclusively breastfeed (EBF) from birth to 3 mo (AOR, 2.55; 95% CI, 1.95-3.35) and 3-6 mo (AOR, 1.75; 95% CI, 1.36-2.25), and, among households randomized to receive extra modules on sanitation and hygiene, have soap and water at a handwashing station (AOR, 1.76; 95% CI, 1.29-2.39). Mothers experiencing time stress were less likely to EBF from birth to 3 mo (AOR, 0.79; 95% CI, 0.66-0.93). Greater social support was associated with institutional delivery (AOR, 1.53; 95% CI, 1.37-1.98) and, among mothers randomized to receive extra complementary feeding modules, feeding children a minimally diverse diet (AOR, 1.18; 95% CI, 1.01-1.37). Depressed mothers were 37% and 33%, respectively, less likely to have an institutional delivery (AOR, 0.63; 95% CI, 0.44-0.88) and a fully immunized child (AOR, 0.67; 95% CI, 0.50-0.90)., Conclusions: Interventions to reduce maternal depression, time stress, inadequate social support, and inequitable gender norms may improve maternal child caregiving., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Society for Nutrition.)

Although mandatory fortification of oil with vitamin A is efficacious, its effectiveness can be compromised by suboptimal compliance to standards. In this study, we assessed (1) the availability of oil brands across the eight divisions of Bangladesh, (2) fortification quality (the extent to which vitamin A content is aligned with fortification standards) of oil brands and producers and (3) the market volume represented by available edible oil types. We visited different retail outlets in rural and urban market hubs to ascertain available oil brands and bulk oil types and collected samples. We used high-performance liquid chromatography to quantify average vitamin A content and compared them to the national oil fortification standards. Among the 66 packaged brands analyzed, 26 (39%) were not fortified, and 40 (61%) were fortified, with 28 (42%) fortified above the standard vitamin A minimum. Among the 41 bulk oil type composites analyzed, 24 (59%) were not fortified, and 17 (41%) were fortified, with 14 (34%) fortified below and 3 (7%) fortified above the standard minimum. Vitamin A fortification is high for packaged and branded edible oil but low for oil sold in unbranded, loose form. As bulk oil makes up a large proportion of the oil market volume, this means the majority of the oil volume available to the population is either not (25%) or fortified below the standard requirement (39%). Regulatory inspections of producers selling bulk oil should be prioritized to support and incentivize the industry to make all oil traceable and fortified to standard.

Background: Clinical outcomes of children who are human immunodeficiency virus (HIV)-exposed in sub-Saharan Africa remain uncertain., Methods: The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial evaluated improved infant and young child feeding (IYCF) and/or improved water, sanitation, and hygiene in 2 rural Zimbabwean districts with 15% antenatal HIV prevalence and > 80% prevention of mother-to-child transmission (PMTCT) coverage. Children born between February 2013 and December 2015 had longitudinal HIV testing and anthropometry. We compared mortality and growth between children who were HIV-exposed and HIV-unexposed through 18 months. Children receiving IYCF were excluded from growth analyses., Results: Fifty-one of 738 (7%) children who were HIV-exposed and 198 of 3989 (5%) children who were HIV-unexposed (CHU) died (hazard ratio, 1.41 [95% confidence interval {CI}, 1.02-1.93]). Twenty-five (3%) children who were HIV-exposed tested HIV positive, 596 (81%) were HIV-exposed uninfected (CHEU), and 117 (16%) had unknown HIV status by 18 months; overall transmission estimates were 4.3%-7.7%. Mean length-for-age z score at 18 months was 0.38 (95% CI, .24-.51) standard deviations lower among CHEU compared to CHU. Among 367 children exposed to HIV in non-IYCF arms, 147 (40%) were alive, HIV-free, and nonstunted at 18 months, compared to 1169 of 1956 (60%) CHU (absolute difference, 20% [95% CI, 15%-26%])., Conclusions: In rural Zimbabwe, mortality remains 40% higher among children exposed to HIV, vertical transmission exceeds elimination targets, and half of CHEU are stunted. We propose the composite outcome of "alive, HIV free, and thriving" as the long-term goal of PMTCT programs., Clinical Trials Registration: NCT01824940., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.)

Background: Anemia, iron deficiency, and iodine deficiency are problems of important public health concern in many parts of the world, with consequences for the health, development, and work capacity of populations. Several countries are beginning to implement double fortified salt (DFS) programs to simultaneously address iodine and iron deficiencies., Objective: Our objective was to summarize the evidence for efficacy and effectiveness of DFS on the full range of status and functional outcomes and across different implementation and evaluation designs essential to successful interventions., Methods: We conducted a systematic review and meta-analysis of published and gray literature examining the effects of DFS on nutritional status, cognition, work productivity, development, and morbidity of all population groups. We searched for articles in Medline, Embase, CINAHL, Cochrane Central Register, and ProQuest for randomized trials, quasi-randomized trials, and program effectiveness evaluations., Results: A total of 22 studies (N individuals = 52,758) were included. Efficacy studies indicated a significant overall positive effect on hemoglobin concentration [standardized mean difference (95% CI): 0.33 (0.18, 0.48)], ferritin [0.42 (0.08, 0.76)], anemia [risk ratio (95% CI): 0.80 (0.70, 0.92)], and iron deficiency anemia [0.36 (0.24, 0.55)]. Effects on urinary iodine concentration were not significantly different between DFS and iodized salt. The impact on functional outcomes was mixed. Only 2 effectiveness studies were identified. They reported programmatic challenges including low coverage, suboptimal DFS quality, and storage constraints., Conclusions: Given the biological benefits of DFS across several populations in efficacy research, additional evaluations of robust DFS programs delivered at scale, which consider effective implementation and measure appropriate biomarkers, are needed., (Copyright © The Author(s) on behalf of the American Society for Nutrition 2021.)

Background: Double fortified salt (DFS) is efficacious in addressing iron deficiency, but evidence of its effectiveness is limited. The few published evaluations do not include details on program implementation, limiting their utility for programmatic decisions., Objectives: We sought to characterize the coverage of a DFS program implemented through the Public Distribution System (PDS) in Uttar Pradesh, India, and understand the drivers of DFS adherence., Methods: After 8 mo of implementation, we surveyed 1202 households in 5 districts and collected data on sociodemographic characteristics, asset ownership, food security, and regular PDS utilization. We defined DFS program coverage as the proportion of PDS beneficiaries who had heard of and purchased DFS, and we defined DFS adherence as DFS use reported by households. We used principal component analysis to create an asset-based index of relative wealth, and we categorized households into higher/lower relative wealth quintiles. We conducted path analyses to examine the drivers of DFS adherence, particularly the mediated influence of household wealth on DFS adherence. The evaluation is registered with 3ie's Registry for International Development Impact Evaluations (RIDIE-STUDY-ID-58f6eeb45c050)., Results: The DFS program had good coverage: 83% of respondents had heard of DFS and 74% had purchased it at least once. However, only 23% exclusively used DFS. Respondents had low awareness about DFS benefits and considered DFS quality as poor. Being in a lower household wealth quintile and being food insecure were significant drivers of DFS adherence, and regular PDS utilization acted as a mediator. Adherence was lower in urban areas., Conclusions: We observed significant heterogeneity in DFS implementation as reflected by high coverage and low adherence. Findings from this process evaluation informed the design of an adaptive impact evaluation and provided generalizable insights for ensuring that the potential for impact is realized. Efforts are needed to increase awareness, improve product quality, as well as mitigate against the sensory challenges identified., (Copyright © The Author(s) on behalf of the American Society for Nutrition 2020.)

Background: Food fortification is implemented to increase intakes of specific nutrients in the diet, but contributions of fortified foods to nutrient intakes are rarely quantified., Objectives: We quantified iron, vitamin A, and iodine intakes from fortified staple foods and condiments among women of reproductive age (WRA)., Methods: In subnational (Nigeria, South Africa) and national (Tanzania, Uganda) cross-sectional, clustered household surveys, we assessed fortifiable food consumption. We estimated daily nutrient intakes from fortified foods among WRA by multiplying the daily apparent fortifiable food consumption (by adult male equivalent method) by a fortification content for the food. Two fortification contents were used: measured, based on the median amount quantified from individual food samples collected from households; and potential, based on the targeted amount in national fortification standards. Results for both approaches are reported as percentages of the estimated average requirement (EAR) and recommended nutrient intake (RNI)., Results: Fortified foods made modest contributions to measured iron intakes (0%-13% RNI); potential intakes if standards are met were generally higher (0%-65% RNI). Fortified foods contributed substantially to measured vitamin A and iodine intakes (20%-125% and 88%-253% EAR, respectively); potential intakes were higher (53%-655% and 115%-377% EAR, respectively) and would exceed the tolerable upper intake level among 18%-56% of WRA for vitamin A in Nigeria and 1%-8% of WRA for iodine in Nigeria, Tanzania, and Uganda., Conclusions: Fortified foods are major contributors to apparent intakes of vitamin A and iodine, but not iron, among WRA. Contributions to vitamin A and iodine are observed despite fortification standards not consistently being met and, if constraints to meeting standards are addressed, there is risk of excessive intakes in some countries. For all programs assessed, nutrient intakes from all dietary sources and fortification standards should be reviewed to inform adjustments where needed to avoid risk of low or excessive intakes., (Copyright © The Author(s) on behalf of the American Society for Nutrition 2020.)

Background: Biofortification of staple crops has the potential to increase nutrient intakes and improve health outcomes. Despite program data on the number of farming households reached with and growing biofortified crops, information on the coverage of biofortified foods in the general population is often lacking. Such information is needed to ascertain potential for impact and identify bottlenecks to parts of the impact pathway., Objectives: We aimed to develop and test methods and indicators for assessing household coverage of biofortified foods., Methods: To assess biofortification programs, 5 indicators of population-wide household coverage were developed, building on approaches previously used to assess large-scale food fortification programs. These were 1 ) consumption of the food; 2 ) awareness of the biofortified food; 3 ) availability of the biofortified food; 4 ) consumption of the biofortified food (ever); and 5 ) consumption of the biofortified food (current). To ensure that the indicators are applicable to different settings they were tested in a cross-sectional household-based cluster survey in rural and peri-urban areas in Musanze District, Rwanda where planting materials for iron-biofortified beans (IBs) and orange-fleshed sweet potatoes (OFSPs) were delivered., Results: Among the 242 households surveyed, consumption of beans and sweet potatoes was 99.2% and 96.3%, respectively. Awareness of IBs or OFSPs was 65.7% and 48.8%, and availability was 23.6% and 10.7%, respectively. Overall, 15.3% and 10.7% of households reported ever consuming IBs and OFSPs, and 10.4% and 2.1% of households were currently consuming these foods, respectively. The major bottlenecks to coverage of biofortified foods were awareness and availability., Conclusions: These methods and indicators fill a gap in the availability of tools to assess coverage of biofortified foods, and the results of the survey highlight their utility for identifying bottlenecks. Further testing is warranted to confirm the generalizability of the coverage indicators and inform their operationalization when deployed in different settings., (Copyright © The Author(s) on behalf of the American Society for Nutrition 2020.)

Large-scale food fortification (LSFF) is a cost-effective intervention that is widely implemented, but there is scope to further increase its potential. To identify gaps and opportunities, we first accessed the Global Fortification Data Exchange (GFDx) to identify countries that could benefit from new fortification programs. Second, we aggregated Fortification Assessment Coverage Toolkit (FACT) survey data from 16 countries to ascertain LSFF coverage and gaps therein. Third, we extended our narrative review to assess current innovations. We identified 84 countries as good candidates for new LSFF programs. FACT data revealed that the potential of oil/ghee and salt fortification is not being met due mainly to low coverage of adequately fortified foods (quality). Wheat, rice and maize flour fortification have similar quality issues combined with lower coverage of the fortifiable food at population-level (< 50%). A four-pronged strategy is needed to meet the unfinished agenda: first, establish new LSFF programs where warranted; second, systems innovations informed by implementation research to address coverage and quality gaps; third, advocacy to form new partnerships and resources, particularly with the private sector; and finally, exploration of new fortificants and vehicles (e.g. bouillon cubes; salt fortified with multiple nutrients) and other innovations that can address existing challenges., Competing Interests: The authors declare no conflict of interest. All authors are employed by organizations which receive funding from several donors to support food fortification programs in many countries. Mawuli Sablah is a UNICEF staff member and the opinions and statements in this article are those of the author and may not reflect official UNICEF policies.

A theory-driven evaluation was conducted to assess performance of a trial to deliver micronutrient powder (MNP) through the Ethiopian Ministry of Health. We adapted an approach to coverage assessment, originally developed to identify bottlenecks in health service delivery, to examine sequential program outcomes and their correlates using cross-sectional survey data of caregivers of children 6-23 months (N = 1915). Separate multivariable Poisson regression models were used to estimate adjusted risk ratios of conceptually relevant determinants of coverage and adherence. Caregivers of children >11 months were more likely to have received MNP than caregivers of younger infants, yet children 12-17 months were 32% (P < 0.001) and children 18-23 months 38% (P < 0.001) less likely to have been fed MNP in the 14 days preceding the survey than children 6-11 months. Among caregivers who initiated feeding MNP, the most frequently reported reasons for discontinuing use were not obtaining additional supply (36.1%) and perceived child rejection of food with MNP (22.9%). For each additional time a caregiver met with frontline workers in the 3 months preceding the survey, they were 13% more likely to have recently fed MNP (P < 0.001). Caregivers' perception that MNP produced positive changes in children was associated with a 14% increase in the likelihood of having recently fed it (P < 0.001). These results emphasize the importance of counselling for MNP and infant and young child feeding for initial use and the importance of multiple contacts with frontline workers for continued use., (© 2019 The Authors. Maternal & Child Nutrition Published by John Wiley & Sons Ltd.)

Background: Micronutrient malnutrition is highly prevalent in low- and middle-income countries (LMICs) and disproportionately affects women and children. Although the effectiveness of large-scale food fortification (LSFF) of staple foods to prevent micronutrient deficiencies in high-income settings has been demonstrated, its effectiveness in LMICs is less well characterized. This is important as food consumption patterns, potential food vehicles, and therefore potential for impact may vary substantially in these contexts., Objectives: The aim of this study was to determine the real-world impact of LSFF with key micronutrients (vitamin A, iodine, iron, folic acid) on improving micronutrient status and functional health outcomes in LMICs., Methods: All applicable published/unpublished evidence was systematically retrieved and analyzed. Studies were not restricted by age or sex. Meta-analyses were performed for quantitative outcomes and results were presented as summary RRs, ORs, or standardized mean differences (SMDs) with 95% CIs., Results: LSFF increased serum micronutrient concentrations in several populations and demonstrated a positive impact on functional outcomes, including a 34% reduction in anemia (RR: 0.66; 95% CI: 0.59, 0.74), a 74% reduction in the odds of goiter (OR: 0.26; 95% CI: 0.16, 0.43), and a 41% reduction in the odds of neural tube defects (OR: 0.59; 95% CI: 0.49, 0.70). Additionally, we found that LSFF with vitamin A could protect nearly 3 million children per year from vitamin A deficiency. We noted an age-specific effect of fortification, with women (aged >18 y) attaining greater benefit than children, who may consume smaller quantities of fortified staple foods. Several programmatic/implementation factors were also reviewed that may facilitate or limit program potential., Conclusions: Measurable improvements in the micronutrient and health status of women and children are possible with LSFF. However, context and implementation factors are important when assessing programmatic sustainability and impact, and data on these are quite limited in LMIC studies., (Copyright © American Society for Nutrition 2019.)

Background: Globally, nearly 250 million children (43% of all children under 5 years of age) are at risk of compromised neurodevelopment due to poverty, stunting, and lack of stimulation. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved infant and young child feeding (IYCF) on early child development (ECD) among children enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe., Methods and Findings: SHINE was a cluster-randomized community-based 2×2 factorial trial. A total of 5,280 pregnant women were enrolled from 211 clusters (defined as the catchment area of 1-4 village health workers [VHWs] employed by the Zimbabwean Ministry of Health and Child Care). Clusters were randomly allocated to standard of care, IYCF (20 g of small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counseling), WASH (ventilated improved pit latrine, handwashing stations, chlorine, liquid soap, and play yard), and WASH + IYCF. Primary outcomes were child length-for-age Z-score and hemoglobin concentration at 18 months of age. Children who completed the 18-month visit and turned 2 years (102-112 weeks) between March 1, 2016, and April 30, 2017, were eligible for the ECD substudy. We prespecified that primary inferences would be drawn from findings of children born to HIV-negative mothers; these results are presented in this paper. A total of 1,655 HIV-unexposed children (64% of those eligible) were recruited into the ECD substudy from 206 clusters and evaluated for ECD at 2 years of age using the Malawi Developmental Assessment Tool (MDAT) to assess gross motor, fine motor, language, and social skills; the MacArthur-Bates Communicative Development Inventories (CDI) to assess vocabulary and grammar; the A-not-B test to assess object permanence; and a self-control task. Outcomes were analyzed in the intention-to-treat population. For all ECD outcomes, there was not a statistical interaction between the IYCF and WASH interventions, so we estimated the effects of the interventions by comparing the 2 IYCF groups with the 2 non-IYCF groups and the 2 WASH groups with the 2 non-WASH groups. The mean (95% CI) total MDAT score was modestly higher in the IYCF groups compared to the non-IYCF groups in unadjusted analysis: 1.35 (0.24, 2.46; p = 0.017); this difference did not persist in adjusted analysis: 0.79 (-0.22, 1.68; p = 0.057). There was no evidence of impact of the IYCF intervention on the CDI, A-not-B, or self-control tests. Among children in the WASH groups compared to those in the non-WASH groups, mean scores were not different for the MDAT, A-not-B, or self-control tests; mean CDI score was not different in unadjusted analysis (0.99 [95% CI -1.18, 3.17]) but was higher in children in the WASH groups in adjusted analysis (1.81 [0.01, 3.61]). The main limitation of the study was the specific time window for substudy recruitment, meaning not all children from the main trial were enrolled., Conclusions: We found little evidence that the IYCF and WASH interventions implemented in SHINE caused clinically important improvements in child development at 2 years of age. Interventions that directly target neurodevelopment (e.g., early stimulation) or that more comprehensively address the multifactorial nature of neurodevelopment may be required to support healthy development of vulnerable children., Trial Registration: ClinicalTrials.gov NCT01824940., Competing Interests: The authors have declared no competing interests exist.

Background: Suboptimal breastfeeding contributes to >800,000 global child deaths annually. Optimal breastfeeding includes early initiation (EI) and exclusive breastfeeding (EBF) for the first 6 mo., Objectives: We tested the hypothesis that an intervention targeting context and infant age-specific barriers to EI and EBF will achieve a higher EI and EBF prevalence than those of women participating in the concurrently conducted 2015 Zimbabwe Demographic Health Survey (Z-DHS)., Methods: We designed an intervention to promote EI and EBF, and implemented it within the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe. Intervention modules were delivered at 4 perinatal time points by government-employed village health workers. We compared EI and EBF prevalence among SHINE women who provided outcomes at 1 mo ( n  = 2442) and 3 mo ( n  = 2728), with women in the 2015 Z-DHS., Results: In cross-sectional analyses EI prevalence was 86.6% and 64.3% in the SHINE and Z-DHS samples, respectively; absolute difference (95% CI) = 22.4% (17.5%, 27.3%). EBF prevalence was similarly high (>80%) in both surveys during the first month of life; during 1 to <2 mo, 2 to <3 mo, 3 to <4 mo, 4 to <5 mo, and 5 to <6 mo, EBF prevalence was, respectively, 85%, 90%, 90%, 84%, and 75% in SHINE, and 71%, 65%, 35%, 26%, and 25% in Z-DHS; absolute difference (95% CI) = 50.2% (34.7%, 65.7%) at 5 to <6 mo. Cesarean delivery, mother's belief that intimate partner violence was sometimes justifiable, and having a male infant negatively modified the effects of the intervention., Conclusions: The SHINE intervention achieved a high prevalence of EI and EBF. Concurrently addressing gender norms will be critical to make further progress. Formative studies to identify context- and infant age-specific barriers to EI and EBF may inform improvement of breastfeeding practices elsewhere. Important work remains to scale up this intervention beyond a research setting. SHINE was registered at www.clinicaltrials.gov as NCT01824940.

Background: Children exposed to HIV have a high prevalence of stunting and anaemia. We aimed to test the effect of improved infant and young child feeding (IYCF) and improved water, sanitation, and hygiene (WASH) on child linear growth and haemoglobin concentrations., Methods: We did a cluster randomised 2 × 2 factorial trial in two districts in rural Zimbabwe. Women were eligible for inclusion if they permanently lived in the trial clusters (ie, the catchment area of between one and four village health workers employed by the Zimbabwean Ministry of Health and Child Care) and were confirmed pregnant. Clusters were randomly allocated to standard of care (52 clusters); IYCF (20 g small-quantity lipid-based nutrient supplement daily for infants from 6 months to 18 months, complementary feeding counselling with context-specific messages, longitudinal delivery, and reinforcement; 53 clusters); WASH (ventilated, improved pit latrine, two hand-washing stations, liquid soap, chlorine, play space, and hygiene counselling; 53 clusters); or IYCF plus WASH (53 clusters). Participants and fieldworkers were not masked. Our co-primary outcomes were length for age Z score and haemoglobin in infants at 18 months of age. Here, we report these outcomes in the HIV-exposed children, analysed by intention to treat. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes with an important statistical interaction between the interventions. The trial is registered at ClinicalTrials.gov (NCT01824940) and is now complete., Findings: Between Nov 22, 2012, and March 27, 2015, 726 HIV-positive pregnant women were included in the trial. 668 children were evaluated at 18 months (147 from 46 standard of care clusters; 147 from 48 IYCF clusters; 184 from 44 WASH clusters; 190 from 47 IYCF plus WASH clusters). Of the 668 children, 22 (3%) were HIV-positive, 594 (89%) HIV-exposed uninfected, and 52 (8%) HIV-unknown. The IYCF intervention increased mean length for age Z score by 0·26 (95% CI 0·09-0·43; p=0·003) and haemoglobin concentration by 2·9 g/L (95% CI 0·90-4·90; p=0·005). 165 (50%) of 329 children in the non-IYCF groups were stunted, compared with 136 (40%) of 336 in the IYCF groups (absolute difference 10%, 95% CI 2-17); and the prevalence of anaemia was also lower in the IYCF groups (45 [14%] of 319) than in the non-IYCF groups (24 [7%] of 329; absolute difference 7%, 95% CI 2-12). The WASH intervention had no effect on length or haemoglobin concentration. There were no trial-related adverse or serious adverse events., Interpretation: Since HIV-exposed children are particularly vulnerable to undernutrition and responded well to improved complementary feeding, IYCF interventions could have considerable benefits in areas of high antenatal HIV prevalence. However, elementary WASH interventions did not lead to improvements in growth., Funding: Bill & Melinda Gates Foundation, UK Aid, Wellcome Trust, Swiss Development Cooperation, US National Institutes of Health, and UNICEF., (Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Child stunting reduces survival and impairs neurodevelopment. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH), and improved infant and young child feeding (IYCF) on stunting and anaemia in in Zimbabwe., Methods: We did a cluster-randomised, community-based, 2 × 2 factorial trial in two rural districts in Zimbabwe. Clusters were defined as the catchment area of between one and four village health workers employed by the Zimbabwe Ministry of Health and Child Care. Women were eligible for inclusion if they permanently lived in clusters and were confirmed pregnant. Clusters were randomly assigned (1:1:1:1) to standard of care (52 clusters), IYCF (20 g of a small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counselling; 53 clusters), WASH (construction of a ventilated improved pit latrine, provision of two handwashing stations, liquid soap, chlorine, and play space plus hygiene counselling; 53 clusters), or IYCF plus WASH (53 clusters). A constrained randomisation technique was used to achieve balance across the groups for 14 variables related to geography, demography, water access, and community-level sanitation coverage. Masking of participants and fieldworkers was not possible. The primary outcomes were infant length-for-age Z score and haemoglobin concentrations at 18 months of age among children born to mothers who were HIV negative during pregnancy. These outcomes were analysed in the intention-to-treat population. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes that had an important statistical interaction between the interventions. This trial is registered with ClinicalTrials.gov, number NCT01824940., Findings: Between Nov 22, 2012, and March 27, 2015, 5280 pregnant women were enrolled from 211 clusters. 3686 children born to HIV-negative mothers were assessed at age 18 months (884 in the standard of care group from 52 clusters, 893 in the IYCF group from 53 clusters, 918 in the WASH group from 53 clusters, and 991 in the IYCF plus WASH group from 51 clusters). In the IYCF intervention groups, the mean length-for-age Z score was 0·16 (95% CI 0·08-0·23) higher and the mean haemoglobin concentration was 2·03 g/L (1·28-2·79) higher than those in the non-IYCF intervention groups. The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845. The WASH intervention had no effect on either primary outcome. Neither intervention reduced the prevalence of diarrhoea at 12 or 18 months. No trial-related serious adverse events, and only three trial-related adverse events, were reported., Interpretation: Household-level elementary WASH interventions implemented in rural areas in low-income countries are unlikely to reduce stunting or anaemia and might not reduce diarrhoea. Implementation of these WASH interventions in combination with IYCF interventions is unlikely to reduce stunting or anaemia more than implementation of IYCF alone., Funding: Bill & Melinda Gates Foundation, UK Department for International Development, Wellcome Trust, Swiss Development Cooperation, UNICEF, and US National Institutes of Health., (Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Poverty and human capital development are inextricably linked and therefore research on human capital typically incorporates measures of economic well-being. In the context of randomized trials of health interventions, for example, such measures are used to: 1) assess baseline balance; 2) estimate covariate-adjusted analyses; and 3) conduct subgroup analyses. Many factors characterize economic well-being, however, and analysts often generate summary measures such as indices of household socio-economic status or wealth. In this paper, a household wealth index is developed and tested for participants in the cluster-randomized Sanitation, Hygiene, Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe., Methods: Building on the approach used in the Zimbabwe Demographic and Health Survey (ZDHS), we combined a set of housing characteristics, ownership of assets and agricultural resources into a wealth index using principal component analysis (PCA) on binary variables. The index was assessed for internal and external validity. Its sensitivity was examined considering an expanded set of variables and an alternative statistical approach of polychoric PCA. Correlation between indices was determined using the Spearman's rank correlation coefficient and agreement between quintiles using a linear weighted Kappa statistic. Using the 2015 ZDHS data, we constructed a separate index and applied the loadings resulting from that analysis to the SHINE study population, to compare the wealth distribution in the SHINE study with rural Zimbabwe., Results: The derived indices using the different methods were highly correlated (r>0.9), and the wealth quintiles derived from the different indices had substantial to near perfect agreement (linear weighted Kappa>0.7). The indices were strongly associated with a range of assets and other wealth measures, indicating both internal and external validity. Households in SHINE were modestly wealthier than the overall population of households in rural Zimbabwe., Conclusion: The SHINE wealth index developed here is a valid and robust measure of wealth in the sample., Competing Interests: The authors have declared that no competing interests exist.

Scope: Aflatoxins (AFs) are toxic secondary metabolites of Aspergillus species that contaminate staple foods such as maize and groundnuts. AF exposure during pregnancy has been associated with adverse birth outcomes in limited-scale surveys in sub-Saharan Africa. The objective of this study was to describe the determinants of AF exposure, using urinary aflatoxin M1 (AFM1) biomarkers and data generated by the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial for rural Zimbabwean women in early pregnancy. Sanitation Hygiene Infant Nutrition Efficacy is a large, cluster-randomized community-based trial in Zimbabwe designed to investigate the independent and combined effects of nutrition and hygiene interventions on early child growth., Methods and Results: Urine samples collected from 1580 pregnant women in rural Zimbabwe at median gestational age of 13.9 wk were measured for AFM1. AFM1 was detected in 30% of samples (median of exposed, 162 pg AFM1/mg creatinine; range 30-6046 pg AFM1/mg). In multivariable ordinal logistic models, geographical location (p<0.001), seasonality (p < 0.001) and dietary practices (p = 0.011) were significant predictors of urinary AFM1., Conclusion: This is the largest AF biomarker survey conducted in Zimbabwe, and demonstrated frequent exposure in pregnant women with clear temporal and spatial variability in AF biomarker levels., (© 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)