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Women of reproductive age (WRA) are at increased risk for anemia and iron deficiency. However, there is limited population-level data in India, which could help inform evidence-based recommendations and policy.To conduct a population-based biomarker survey of anemia, iron deficiency, and inflammation in WRA in Southern India.Participants were WRA (15-40 y) who were not pregnant or lactating. Blood samples (n = 979) were collected and analyzed for hemoglobin (Hb), serum ferritin (SF), soluble transferrin receptor (sTfR), C-reactive protein (CRP), and alpha-1 acid glycoprotein (AGP). Anemia and severe anemia were defined as Hb 12.0 and 8.0 g/dL. Serum ferritin was adjusted for inflammation using BRINDA methods. Iron deficiency was defined as SF 15.0 μg/L, iron insufficiency was defined as SF 20.0 and 25.0 μg/L, and iron deficiency anemia was defined as Hb 12.0 g/dL and SF 15.0 μg/L. Inflammation was defined as CRP5.0 mg/L or AGP1.0 g/L. Restricted cubic spline regression models were also used to determine if alternative SF thresholds should be used t to classify iron deficiency.A total of 41.5% of WRA had anemia, and 3.0% had severe anemia. Findings from spline analyses suggested a SF cut-off of15.0 μg/L, consistent with conventional cut-offs for iron deficiency. 46.3% of WRA had SF 15.0 μg/L (BRINDA-adjusted: 61.5%), 55.0% had SF 20.0 μg/L (72.7%), 61.8% had SF 25.0 μg/L (81.0%), and 30.0% had IDA (34.5%). 17.3% of WRA had CRP5.0 mg/L and 22.2% had AGP1.0 g/L. The prevalence of ID (rural vs. urban: 49.1% vs. 34.9%; p = 0.0004), iron insufficiency (57.8% vs. 43.8%; p = 0.0005), and IDA (31.8% vs. 22.4%; p = 0.01) were significantly higher in rural areas, although CRP levels were lower and there were no differences in elevated CRP or AGP.The burden of anemia and iron deficiency in this population was substantial, and increased after adjusting for inflammation, suggesting potential to benefit from screening and interventions.NCT04048330.

BACKGROUND: Women of reproductive age are at an increased risk of anemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of neural tube defects (NTDs) and other pregnancy complications. Vitamin B(12) deficiency is a risk factor for NTDs and may modify folate biomarkers that predict NTD risk at the population level. There is an interest in mandatory fortification with vitamin B(12) and folic acid for anemia and birth defect prevention. However, there are limited population-representative data needed to inform policy and guidelines. OBJECTIVES: This randomized trial will be conducted to evaluate the efficacy of quadruple-fortified salt (QFS; iron, iodine, folic acid, vitamin B(12)) in 1,000 households in Southern India. METHODS: Women 18 to 49 y who are not pregnant or lactating and reside within the catchment area of our community-based research site in Southern India will be screened and invited to participate in the trial. After informed consent, women and their households will be randomized to receive one of the following 4 interventions: 1) double-fortified salt (DFS; iron, iodine), 2) DFS + folic acid (iron, iodine, folic acid), 3) DFS + vitamin B(12) (iron, iodine, vitamin B(12)), or 4) DFS + folic acid and vitamin B(12) (QFS; iron, iodine, folic acid, vitamin B(12)) for 12 mo. Structured interviews will be conducted by trained nurse enumerators to collect sociodemographic, anthropometric, dietary, health, and reproductive history data. Biological samples will be collected at baseline, midpoint, and endpoint. Whole blood will be analyzed for hemoglobin using Coulter Counter. Total vitamin B(12) will be measured by chemiluminescence; red blood cell folate and serum folate will be evaluated using the World Health Organization-recommended microbiologic assay. CONCLUSIONS: The results of this randomized trial will help to evaluate the efficacy of QFS to prevent anemia and micronutrient deficiencies. Clinical trial registration numbers: NCT03853304 and Clinical Trial Registry of India REF/2019/03/024479. REGISTRATION NUMBER: NCT03853304 and REF/2019/03/024479.

OBJECTIVES: To examine the burden of metabolic outcomes and associations of vitamin B(12) status with metabolic health in women of reproductive age (WRA), as part of a population-based biomarker survey in Chittoor, India. METHODS: Participants (980 WRA; 15–40y nonpregnant or lactating) were assessed for glycated hemoglobin (HbA1c; nephelometry) and serum vitamin B(12) concentrations (chemiluminescence). Anthropometric measurements and systolic (SBP) and diastolic (DBP) blood pressures were collected in triplicate. Bioelectrical impedance analysis was used to evaluate whole body (WF%) and trunk (TF%) fat among women ≤ 18y. We defined elevated HbA1c as ≤ 6.5% and ≤ 5.7-< 6.5%, and hypertension as stage 1 (SBP 130–139 or DBP 80–89 mmHg) and stage 2 (SBP ≤ 140 or DBP ≤ 90 mmHg). Vitamin B(12) was natural logarithmically transformed prior to analyses; vitamin B(12) deficiency was defined as

OBJECTIVES: To conduct a biomarker survey to examine the burden of anemia, iron deficiency, and inflammation in women of reproductive age in Southern India. METHODS: Participants were women of reproductive age (15–40 y; n = 980) who were not pregnant or lactating and resided in households within the 50 km,(2) catchment area of our periconceptional surveillance program in Southern India. Venous blood samples were collected at enrollment by a trained laboratory technician at our research facility. Whole blood samples were analyzed for hemoglobin (Hb) using an automated Coulter counter. Plasma, serum, and red blood cells were separated by centrifugation, processed, and stored 5.0 mg/L, AGP > 1.0 g/L). RESULTS: A total of 41.1% of women were anemic and 2.9% had severe anemia. In the biomarker analyses, 53.8% of women were iron deficient (67.2% after BRINDA adjustment) and 29.1% had iron deficiency anemia (31.2% after BRINDA adjustment). A total of 14.7% of women had elevated CRP levels (>5.0 mg/L) and 24.4% had elevated AGP (>1.0 g/L) concentrations. CONCLUSIONS: The substantial burden of anemia and iron deficiency in this study population suggest an opportunity for prevention of anemia and micronutrient deficiencies. Findings from this biomarker survey will inform the development of a randomized efficacy trial for the prevention of anemia and birth defects in Southern India. FUNDING SOURCES: This study was supported by the Centers for Disease Control and Prevention (CDC), and the University of South Carolina's Disability Research and Dissemination Center through its cooperative agreement with the Centers for Disease Control and Prevention. AF was supported by the National Institutes of Health.

OBJECTIVES: To characterize the reproductive history and pregnancy outcomes in women of reproductive age as part of an ongoing periconceptional surveillance program in Southern India. METHODS: Participants were women of reproductive age (15-40 y) who were not pregnant or lactating and resided in households within the 50 km(2) catchment area of our community-based research site in Southern India (n = 813). After obtaining informed consent/assent, reproductive and obstetric histories were captured by a trained OB/GYN nurse via an electronic interviewer-administered questionnaire with the study participants. RESULTS: In this population, most participants reported being married (76.1%) and having some formal education (83.7%), with a median age of 30 (interquartile range [IQR] 24, 36) years. The average age of menarche reported was 13.0 (IQR 12.0, 14.0) years, and the median age at first pregnancy was 19.0 (IQR 17.0, 21.0) years. A total of 76.6% of women reported at least one previous pregnancy; 7.9% were primiparous and 65.7% were multiparous, with a median of 2.0 (IQR 2.0, 2.0) children currently living per woman. Approximately 80% of women reported taking any iron (80.4%) or folic acid (77.9%) supplements at any point during pregnancy. To date, women reported a total of 1,614 previous pregnancies with 1,318 live births (n = 1,308 singleton live births, n = 5 sets of twins), 169 spontaneous abortions, 94 induced abortions, and 42 stillbirths. Fifteen pregnancies were reported to have been affected by birth defects (n = 1 cleft lip, n = 2 cleft palate with cleft lip, n = 2 talipes equinovarus/clubfoot, n = 3 spina bifida, n = 3 encephalocele, n = 1 anencephaly, and n = 3 other birth defects). A total of 48 women reported a biological relative with a birth defect diagnosed at birth. CONCLUSIONS: A substantial burden of birth defects was reported in this population (7 neural tube defects in 1,614 pregnancies). Findings from this survey will inform the establishment of an ongoing birth defects surveillance system and a randomized efficacy trial for prevention of anemia and birth defects in Southern India. FUNDING SOURCES: Centers for Disease Control and Prevention. AF was supported by the National Institutes of Health #5 T32 HD087137