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Early Life Thiamine Study
Sponsor: Mount Saint Vincent University
Summary
Thiamine (vitamin B1) is an important nutrient needed for energy metabolism, brain development, and overall health. However, low thiamine intake is a concern in countries where white rice is the main staple since it contains little thiamine. If pregnant or breastfeeding women do not eat enough thiamine, their babies may also become deficient. Severe thiamine deficiency can cause beriberi, which can be life-threatening. Milder deficiency during early life may affect brain development. Healthy pregnant women should eat 1.4 mg thiamine daily. In a previous study in rural Cambodia, study investigators found that giving breastfeeding mothers a higher dose of thiamine (10mg per day) improved their infants' brain development at six months of age. However, supplementation began two weeks after birth. Since much of an infant's brain development occurs in utero, starting mother's supplementation earlier - in pregnancy - may provide greater benefits. Study investigators are now conducting a study with pregnant women in Cambodia. Participants will receive either the usual amount of thiamine found in multiple micronutrient supplements or a higher dose, beginning in pregnancy and continuing until their child is 18 months old. The primary outcome is cognition at 18 months, to see whether higher thiamine intake during pregnancy and early childhood leads to measurable improvements in early brain development.
Official title: Early Life Thiamine Supplementation for Infant Neurocognitive Benefits: a Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
1972
Start Date
2026-06-01
Completion Date
2029-03-31
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Multiple micronutrient supplementation
Standard of Care+ group From 12-16 weeks gestation through to 6 months postnatal, women will consume tablets orally. Starting at 6 months postnatal, supplements will then be administered directly to infants as daily liquid supplement drops. Details of supplement contents are found in the full protocol. Multiple micronutrient supplements will include the standard 15 micronutrients included in the United Nations International Multiple Micronutrient Antenatal Preparation Multiple Micronutrient Supplements (UNIMAPP MMS) formulation, which are the same found in standard micronutrient powders designed for children 6-24 months: thiamine, as well as vitamins A, D, E, K, C, B2, B3, B6, B12, folic acid, iodine, zinc, selenium, and copper. "Standard of Care +" and "High thiamine MMS" groups will take supplements that are identical except for thiamine content. Women: 1.4 mg thiamine Children: 0.5 mg thiamine
Multiple micronutrient supplementation
High thiamine MMS group From 12-16 weeks gestation through to 6 months postnatal, women will consume tablets orally. Starting at 6 months postnatal, supplements will then be administered directly to infants as daily liquid supplement drops. Details of supplement contents are found in the full protocol. Multiple micronutrient supplements will include the standard 15 micronutrients included in the United Nations International Multiple Micronutrient Antenatal Preparation Multiple Micronutrient Supplements (UNIMAPP MMS) formulation, which are the same found in standard micronutrient powders designed for children 6-24 months: thiamine, as well as vitamins A, D, E, K, C, B2, B3, B6, B12, folic acid, iodine, zinc, selenium, and copper. "Standard of Care +" and "High thiamine MMS" groups will take supplements that are identical except for thiamine content. Women: 10 mg thiamine Children: 5 mg thiamine
Locations (1)
Community-based study
Kampong Thom, Cambodia