Early Life Thiamine Study

NCT07795996 | Recruiting

• 1 other identifier: MSVU-REB-2025-234
• Study Type: interventional
• Target: 1,972
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurocognition, Child

Keywords

thiamine (vitamin B1); multiple micronutrient supplements; Cambodia; neurocognition; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Mullen's Scales of Early Learning "Early Learning Composite" T-score (MSEL-ELC)

  Early Learning Composite (ELC) Standard Score is derived from the sum of the age adjusted T-scores for all but the Gross Motor scales: ELC Standard Score = Visual Reception T-Score + Fine Motor T-Score + Receptive Language T-Score + Expressive Language T-Score ELC Standard Score Mean = 100 ELC Standard Score SD = 15 ELC Standard Score Range (Min/Max) = 49 to 155

  18 months postnatal

Other Outcomes (6)

• Mullen's Scales of Early Learning "Early Learning Composite" T-score (MSEL-ELC)

  2 weeks and 6 months postnatal

• Mullen's Scales of Early Learning sub-scales

  2 weeks, 6 months, and 18 months postnatal

• Global Scales of Early Development (GSED)

  2 weeks, 6 months, and 18 months postnatal

Study Arms (2)

Standard of Care +

PLACEBO COMPARATOR

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)

Dietary Supplement: Multiple micronutrient supplementation

High-thiamine MMS

EXPERIMENTAL

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)

Dietary Supplement: Multiple micronutrient supplementation

Interventions

Multiple micronutrient supplementation DIETARY_SUPPLEMENT

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

Standard of Care +

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women aged 18-45 years
• (+0) to 15(+6) weeks pregnant, based on last menstrual period
• planning to breastfeed for at least 6 months

You may not qualify if:

• consumed thiamine-containing supplements in the preceding 3 months
• planning on moving out of province in the next year

Sponsors & Collaborators

• Mount Saint Vincent University: lead
• University of Oregon: collaborator
• Flinders University: collaborator
• Helen Keller International: collaborator
• Institut de Recherche pour le Développement (IRD): collaborator
• Weiss Asset Management Foundation: collaborator
• Factors Group of Nutritional Companies Inc.: collaborator
• NCHADS - Ministry of Health of Cambodia: collaborator

Study Sites (1)

Community-based study

Kampong Thom, Cambodia

RECRUITING

Central Study Contacts

Kyly C Whitfield

CONTACT

902-457-5978; kyly.whitfield@msvu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Applied Human Nutrition

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 31, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)