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

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05901766
• Other study ID #: 2021P002634
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2024
• Est. completion date: November 2025

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: Anne Lee, MD, MPH
• Phone: 6177328343
• Email: alee6[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 pregnancy and lactation? Participants will be randomized to receive a daily iodine-containing multiple micronutrient tablet for 6 months after birth, or routine care. Mothers will provide a breast milk sample and drop of blood at 1 and 6 months. Infants will provide a urine sample and drop of blood at 1 and 6 months of age, and a developmental assessment including an Electroencephalogram at 6 months of age. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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
• 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

Related Conditions & MeSH terms

• Breastfeeding
• Development, Infant
• Iodine Deficiency
• Malnutrition
• Nutrition Poor

Intervention

Dietary Supplement:
• UNIMAP Multiple Micronutrient Supplement
Iodine Containing Multiple Micronutrient Supplement once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Evoked Potentials	P1 Latency	6 months post partum
Primary	BMIC	Breast Milk Iodine Concentration at 1 month	1 month post partum
Secondary	EEG Fc	EEG Functional Connectivity	6 months
Secondary	Infant HCAZ at 6 months	Infant head circumference Z-score	6 months
Secondary	Infant UIC	Infant Urine Iodine Concentration	6 months
Secondary	Infant Tg	Dried blood spot thyroglobulin	6 months
Secondary	Infant TSH	Thyroid Stimulating Hormone	6 months