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Early Life Thiamine Supplementation for Infant Neurocognitive Benefits: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• women aged 18-45 years

• 12(+0) to 15(+6) weeks pregnant, based on last menstrual period

• planning to breastfeed for at least 6 months

Locations
Other Locations
Cambodia
Community-based study
RECRUITING
Kampong Thom
Contact Information
Primary
Kyly C Whitfield
kyly.whitfield@msvu.ca
902-457-5978
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 1972
Treatments
Placebo_comparator: Standard of Care +
multiple micronutrient supplement formulations containing the RNI for thiamine: 1.4 mg/d for pregnant/lactating women (from 12-16 weeks pregnancy through 6 months postnatal), and 0.5 mg/d for children (6-18 months postnatal)
Experimental: High-thiamine MMS
multiple micronutrient supplement formulations containing a higher dose of daily thiamine: 10 mg/d for pregnant/lactating women (12-16 weeks pregnancy through 6 months postnatal), and 5 mg/d for children (6-18 months postnatal)
Related Therapeutic Areas
Sponsors
Leads: Mount Saint Vincent University
Collaborators: Flinders University, NCHADS - Ministry of Health of Cambodia, University of Oregon, Institut de Recherche pour le Développement (IRD), Weiss Asset Management Foundation, Factors Group of Nutritional Companies Inc., Helen Keller International

This content was sourced from clinicaltrials.gov