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

Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Development, Infant; Breastfeeding; Nutrition Poor; Iodine Deficiency
• Intervention / Treatment: Dietary supplement: UNIMMAP Multiple Micronutrient Supplement

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anne Lee, MD, MPH; Phone Number: 401-430-8015; Email: anne_cc_lee@brown.edu
• Study Contact Backup: Name: Kaitlin Mason, MPH, BSN; Email: kaitlin_mason@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine postnatal care; Routine postnatal care per Ethiopian Ministry of Health guidelines
Experimental: Iodine Containing Multiple Micronutrient (UNIMMAP); UNIMMAP 1 tablet po once daily from birth to 6 months postpartum	Dietary supplement: UNIMMAP Multiple Micronutrient Supplement; Iodine Containing Multiple Micronutrient Supplement once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG Power	Absolute power of the alpha band	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Evoked Potentials	P1 Latency	6 months post partum
EEG Fc	EEG Functional Connectivity	6 months
Infant HCAZ at 6 months	Infant head circumference Z-score	6 months
Infant UIC	Infant Urine Iodine Concentration	6 months
BMIC	Breast Milk Iodine Concentration at 3 month	3 month post partum
Infant Tg	Dried blood spot thyroglobulin	3 months
Infant TSH	Thyroid Stimulating Hormone	3 months
Neuromotor response	Generalized movement assessment (GMA)	3 months
Neuromotor response	Hammersmith Infant Neurological Examination (HINE)	6 months
Global development	Global Scales for Early Development (GSED)	6 months
Eye Tracking	Cecile and MAAP visual attention tasks	6 months
Breast milk B vitamin concentration	Breastmilk B-complex vitamin concentration	6 months
Maternal anemia	Maternal hemoglobin	6 months

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Johns Hopkins Bloomberg School of Public Health; Boston Children's Hospital; Brigham and Women's Hospital; University of South Carolina; Addis Continental Institute of Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 4, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Behavior; Nutritional and Metabolic Diseases; Feeding Behavior; Malnutrition; Breast Feeding; Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: 2021P002634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No