Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment

Starting soon · Phase 4

Conditions studied: Iodine Deficiency, Nutrition Poor, Development, Infant, Breastfeeding

In brief

The goal of this clinical trial is to learn about the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers who live in settings with mild iodine deficiency. The main questions it aims to answer are: 1. What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials? 2. What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status? 3. How do iodine and iron interact with each other to affect thyroid function in the mother during lactation? Participants will be randomized to receive a daily multiple micronutrient tablet containing iodine (UNIMAPP) for 6 months postpartum, or routine postnatal care per Ethiopia Ministry of Health. Mothers will provide a breast milk sample and blood at 3 and 6 months postpartum. Infants will provide a urine sample and drop of blood, and have a neurodevelopmental assessment at 3 and 6 months. Researchers will compare the groups that received the iodine-containing micronutrient supplement with the group that received routine care and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.

Key facts

Study ID

NCT05901766

Run by

Brown University

People needed

600

Starts

2026-05-01

Expected to finish

2028-03-31

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

Full record on ClinicalTrials.gov

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