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

Phase 4

Not yet recruiting

• Conditions: Nutrition Poor; Iodine Deficiency; Breastfeeding; Development, Infant
• Interventions: Dietary Supplement: UNIMAP Multiple Micronutrient Supplement

• Registration Number: NCT05901766
• Lead Sponsor: Brown University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Study Start: 2025-05-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodine Containing Multiple Micronutrient (UNIMAP)	UNIMAP Multiple Micronutrient Supplement	UNIMAP 1 tablet po once daily from birth to 6 months postpartum

Primary Outcome Measures

Name	Time	Method
BMIC	1 month post partum	Breast Milk Iodine Concentration at 1 month
Visual Evoked Potentials	6 months post partum	P1 Latency

Secondary Outcome Measures

Name	Time	Method
Infant TSH	6 months	Thyroid Stimulating Hormone
Infant Tg	6 months	Dried blood spot thyroglobulin
EEG Fc	6 months	EEG Functional Connectivity
Infant HCAZ at 6 months	6 months	Infant head circumference Z-score
Infant UIC	6 months	Infant Urine Iodine Concentration