Not Yet RecruitingPhase 4

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

600 participantsStarted 2026-05-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

To be eligible, women will be required to meet the following inclusion criteria: * Maternal age 18 years or above, singleton pregnancy, * data available on Last Menstrual Period (LMP) or early ultrasound, * Intention to exclusively feed breastmilk for 4 to 6 months, * Intention to stay in the study catchment area for at least 6 months, * Willingness to take a daily supplement of MMS for 6 months Exclusion criteria include: * Severe maternal morbidity (postpartum eclampsia, postpartum hemorrhage), * Maternal condition leading to inability for infant to directly/exclusively breastfeed (maternal mastectomy, or other breast surgery), * Breast cancer, * Tuberculosis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

EEG Power

Timeframe: 6 months

Trial details

NCT IDNCT05901766

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-04

Contact for this trial

Anne Lee, MD, MPH

401-430-8015 anne_cc_lee@brown.edu

View on ClinicalTrials.gov More Iodine Deficiency trials