Brown University
Anne Shee CC Lee
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 drop of 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 (IFA) and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.
Iodine Deficiency
Nutrition Poor
Development, Infant
Breastfeeding
UNIMAP Multiple Micronutrient Supplement
PHASE4
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 600 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment |
| Actual Study Start Date : | 2025-05-01 |
| Estimated Primary Completion Date : | 2026-01-01 |
| Estimated Study Completion Date : | 2026-01-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: | 1 |
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