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 (1)

• EEG Power

  Absolute power of the alpha band

  6 months

Secondary Outcomes (13)

• EEG Fc

  6 months

• BMIC

  3 month post partum

• Visual Evoked Potentials

  6 months post partum

• Infant HCAZ at 6 months

  6 months

• Infant UIC

  6 months

Study Arms (2)

Iodine Containing Multiple Micronutrient (UNIMMAP)

EXPERIMENTAL

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

Dietary Supplement: UNIMMAP Multiple Micronutrient Supplement

Routine postnatal care

NO INTERVENTION

Routine postnatal care per Ethiopian Ministry of Health guidelines

Interventions

UNIMMAP Multiple Micronutrient Supplement DIETARY_SUPPLEMENT

Iodine Containing Multiple Micronutrient Supplement once daily

Iodine Containing Multiple Micronutrient (UNIMMAP)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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
• Boston Children's Hospital: 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: May 1, 2026
• Primary Completion (Estimated): October 4, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05