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

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.

NCT Number	NCT05901766
Lead Sponsor	Brown University Collaborators: Addis Continental Institute of Public Health, Brigham and Women's Hospital, Johns Hopkins Bloomberg School of Public Health, University of South Carolina, Boston Children's Hospital
Conditions	Iodine Deficiency, Nutrition Poor, Development, Infant, Breastfeeding
Enrollment	600 participants
Start Date	2026-05-01
Primary Completion	2027-10-04 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-26