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

NCT05901766 | Not Yet Recruiting Phase 4

• 1 other identifier: 2021P002634
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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. 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. 2.What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status?
3. 3.How do iodine and iron interact with each other to affect thyroid function in the mother during lactation?

Conditions

Iodine Deficiency; Nutrition Poor; Development, Infant; Breastfeeding

Outcome Measures

Primary Outcomes (2)

• Visual Evoked Potentials

  P1 Latency

  6 months post partum

• BMIC

  Breast Milk Iodine Concentration at 1 month

  1 month post partum

Secondary Outcomes (5)

• EEG Fc

  6 months

• Infant HCAZ at 6 months

  6 months

• Infant UIC

  6 months

• Infant Tg

  6 months

• Infant TSH

  6 months

Study Arms (2)

Iodine Containing Multiple Micronutrient (UNIMAP)

EXPERIMENTAL

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

Dietary Supplement: UNIMAP Multiple Micronutrient Supplement

Routine postnatal care

NO INTERVENTION

Routine postnatal care per Ethiopian Ministry of Health guidelines

Interventions

UNIMAP Multiple Micronutrient Supplement DIETARY_SUPPLEMENT

Iodine Containing Multiple Micronutrient Supplement once daily

Iodine Containing Multiple Micronutrient (UNIMAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• Addis Continental Institute of Public Health: collaborator
• Brigham and Women's Hospital: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• University of South Carolina: collaborator

MeSH Terms

Conditions

Malnutrition; Breast Feeding

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Central Study Contacts

Anne Lee, MD, MPH

CONTACT

401-430-8015; anne_cc_lee@brown.edu

Kaitlin Mason, MPH, BSN

CONTACT

kaitlin_mason@brown.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Levinger Family Professor of Pediatrics

Model Details: Individually randomized controlled trial

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-08