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

NCT05901766 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Iodine Deficiency
  • Nutrition Poor
  • Development, Infant
  • Breastfeeding

Interventions

DIETARY_SUPPLEMENT

UNIMAP Multiple Micronutrient Supplement

Iodine Containing Multiple Micronutrient Supplement once daily

Sponsors & Collaborators

  • Addis Continental Institute of Public Health

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • University of South Carolina

    collaborator OTHER

  • Brown University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-30
Completion
2027-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05901766 on ClinicalTrials.gov