1. Low-dose thiamine supplementation of lactating Cambodian mothers improves human milk thiamine concentrations: a randomized controlled trial
- Author
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Gallant, Jelisa, Chan, Kathleen, Green, Tim J, Wieringa, Frank T, Leemaqz, Shalem, Ngik, Rem, Measelle, Jeffrey R, Baldwin, Dare A, Borath, Mam, Sophonneary, Prak, Yelland, Lisa N, Hampel, Daniela, Shahab-Ferdows, Setareh, Allen, Lindsay H, Jones, Kerry S, Koulman, Albert, Parkington, Damon A, Meadows, Sarah R, Kroeun, Hou, and Whitfield, Kyly C
- Subjects
Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Research ,Clinical Trials and Supportive Activities ,Nutrition ,Prevention ,Complementary and Integrative Health ,Evaluation of treatments and therapeutic interventions ,3.3 Nutrition and chemoprevention ,Prevention of disease and conditions ,and promotion of well-being ,6.1 Pharmaceuticals ,Reproductive health and childbirth ,Good Health and Well Being ,Adult ,Cambodia ,Dietary Supplements ,Double-Blind Method ,Female ,Humans ,Milk ,Human ,Thiamine ,Vitamin B Complex ,Young Adult ,thiamine ,supplementation ,human milk ,ThDP ,ETKac ,Engineering ,Medical and Health Sciences ,Nutrition & Dietetics ,Clinical sciences ,Nutrition and dietetics - Abstract
BackgroundInfantile beriberi-related mortality is still common in South and Southeast Asia. Interventions to increase maternal thiamine intakes, and thus human milk thiamine, are warranted; however, the required dose remains unknown.ObjectivesWe sought to estimate the dose at which additional maternal intake of oral thiamine no longer meaningfully increased milk thiamine concentrations in infants at 24 wk postpartum, and to investigate the impact of 4 thiamine supplementation doses on milk and blood thiamine status biomarkers.MethodsIn this double-blind, 4-parallel arm randomized controlled dose-response trial, healthy mothers were recruited in Kampong Thom, Cambodia. At 2 wk postpartum, women were randomly assigned to consume 1 capsule, containing 0, 1.2 (estimated average requirement), 2.4, or 10 mg of thiamine daily from 2 through 24 weeks postpartum. Human milk total thiamine concentrations were measured using HPLC. An Emax curve was plotted, which was estimated using a nonlinear least squares model in an intention-to-treat analysis. Linear mixed-effects models were used to test for differences between treatment groups. Maternal and infant blood thiamine biomarkers were also assessed.ResultsIn total, each of 335 women was randomly assigned to1 of the following thiamine-dose groups: placebo (n = 83), 1.2 mg (n = 86), 2.4 mg (n = 81), and 10 mg (n = 85). The estimated dose required to reach 90% of the maximum average total thiamine concentration in human milk (191 µg/L) is 2.35 (95% CI: 0.58, 7.01) mg/d. The mean ± SD milk thiamine concentrations were significantly higher in all intervention groups (183 ± 91, 190 ± 105, and 206 ± 89 µg/L for 1.2, 2.4, and 10 mg, respectively) compared with the placebo group (153 ± 85 µg/L; P
- Published
- 2021