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

NCT ID: NCT05901766

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iodine Containing Multiple Micronutrient (UNIMAP)

UNIMAP 1 tablet po once daily from birth to 6 months postpartum

Group Type: EXPERIMENTAL

UNIMAP Multiple Micronutrient Supplement

Intervention Type: DIETARY_SUPPLEMENT

Iodine Containing Multiple Micronutrient Supplement once daily

Routine postnatal care

Routine postnatal care per Ethiopian Ministry of Health guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

UNIMAP Multiple Micronutrient Supplement

Iodine Containing Multiple Micronutrient Supplement once daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Intention to breast feed at least 3 months
• Birth weight >2000g

Exclusion Criteria

• Intention to primarily feed by alternative sources (formula, animal milk)
• Multiple pregnancy
• Infant with major congenital anomalies
• Infants with severe morbidity or developmental disorder
• Mother with HIV or chronic renal disease
• Plan to move out of study catchment area
• Does not agree to follow up or EEG/VEP

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Addis Continental Institute of Public Health

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Anne Shee CC Lee

Levinger Family Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Anne Lee, MD, MPH

Role: CONTACT

anne_cc_lee@brown.edu

401-430-8015

Kaitlin Mason, MPH, BSN

Role: CONTACT

kaitlin_mason@brown.edu

Other Identifiers

2021P002634

Identifier Type: -

Identifier Source: org_study_id