Trial reportThe American journal of clinical nutrition2021
Low-dose thiamine supplementation of lactating Cambodian mothers improves human milk thiamine concentrations: a randomized controlled trial.
Trial report in The American journal of clinical nutrition, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Improving Estimates of the Global Burden of Thiamine Deficiency Disorders and Approaches to Their Control: Trial of Thiamine Supplementation in Cambodia
A Seamless Phase 2A-Phase 2B Randomized Double-Blind Placebo- Controlled Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Assessing the Discriminatory Ability of Hemoglobin Concentration to Predict Iron Stores in Cambodian Females: A Systematic Review and Individual Participant Data Meta-Analysis.Advances in nutrition (Bethesda, Md.) · 2026Pooled it
- Effects of vitamin and multiple micronutrient supplementation for pregnant and/or lactating women on maternal and infant nutritional status in low- and middle-income countries: a systematic review and meta-analysis.Advances in nutrition (Bethesda, Md.) · 2025Pooled it
- Reference Values for B Vitamins in Human Milk: The Mothers, Infants and Lactation Quality (MILQ) Study.Advances in nutrition (Bethesda, Md.) · 2025Article
- Micronutrient Biomarker Selection and Assay Methods and Performance in Double-Blind, Randomized, Controlled Micronutrient Dose Response (MiNDR) Trials among Women of Reproductive Age and Pregnant Women in Rural Bangladesh.Current developments in nutrition · 2025Article
- Thiamine Concentration in Human Milk Is Correlated With Maternal and Infant Thiamine Status: A Cross-Sectional Analysis of the Lao Thiamine Study.Maternal & child nutrition · 2025Observational
- Dietary assessment using a novel image-voice-based system indicates nutrient inadequacies in Cambodian women's dietary intake.Journal of nutritional science · 2025Observational
- Protocol: the International Milk Composition (IMiC) Consortium - a harmonized secondary analysis of human milk from four studies.Frontiers in nutrition · 2025Article
- Assessment of Erythrocyte Transketolase, Whole Blood Thiamine Diphosphate, and Human Milk Thiamine Concentrations to Identify Infants and Young Children Responding Favorably to Therapeutic Thiamine Administration: Findings from the Lao Thiamine Study, a Prospective Cohort Study.Current developments in nutrition · 2024Article
- Article
- The importance of thiamine (vitamin B1) in humans.Bioscience reports · 2023Article
- Thiamine deficiency in pregnancy and lactation: implications and present perspectives.Frontiers in nutrition · 2023Review
- Pharmacological thiamine levels as a therapeutic approach in Alzheimer's disease.Frontiers in medicine · 2022Article
- Thiamine deficiency in Gambian women of reproductive age.Annals of the New York Academy of Sciences · 2022Article
- The Mothers, Infants, and Lactation Quality (MILQ) Study: A Multi-Center Collaboration.Current developments in nutrition · 2021Article
- Thiamine supplementation holds neurocognitive benefits for breastfed infants during the first year of life.Annals of the New York Academy of Sciences · 2021Article
- B-Vitamins and Choline in Human Milk Are Not Impacted by a Preconception Lipid-Based Nutrient Supplement, but Differ Among Three Low-to-Middle Income Settings-Findings From the Women First Trial.Frontiers in nutrition · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 8 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
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 < 0.0001) and did not significantly differ from each other.
conclusionsA supplemental thiamine dose of 2.35 mg/d was required to achieve a milk total thiamine concentration of 191 µg/L. However, 1.2 mg/d for 22 wk was sufficient to increase milk thiamine concentrations to similar levels achieved by higher supplementation doses (2.4 and 10 mg/d), and comparable to those of healthy mothers in regions without beriberi. This trial was registered at clinicaltrials.gov as NCT03616288.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.