Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment
Primary Purpose
Iodine Deficiency, Nutrition Poor, Development, Infant
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
UNIMAP Multiple Micronutrient Supplement
Sponsored by
About this trial
This is an interventional treatment trial for Iodine Deficiency
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Iodine Containing Multiple Micronutrient (UNIMAP)
Routine care
Arm Description
UNIMAP 1 tablet po once daily from birth to 6 months postpartum
Routine clinical care includes recommendation for iron folic acid for women with anemia
Outcomes
Primary Outcome Measures
Visual Evoked Potentials
P1 Latency
BMIC
Breast Milk Iodine Concentration at 1 month
Secondary Outcome Measures
EEG Fc
EEG Functional Connectivity
Infant HCAZ at 6 months
Infant head circumference Z-score
Infant UIC
Infant Urine Iodine Concentration
Infant Tg
Dried blood spot thyroglobulin
Infant TSH
Thyroid Stimulating Hormone
Full Information
NCT ID
NCT05901766
First Posted
June 5, 2023
Last Updated
July 24, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05901766
Brief Title
Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment
Official Title
Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2024 (Anticipated)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials?
What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iodine Deficiency, Nutrition Poor, Development, Infant, Breastfeeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Individually randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iodine Containing Multiple Micronutrient (UNIMAP)
Arm Type
Experimental
Arm Description
UNIMAP 1 tablet po once daily from birth to 6 months postpartum
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
Routine clinical care includes recommendation for iron folic acid for women with anemia
Intervention Type
Dietary Supplement
Intervention Name(s)
UNIMAP Multiple Micronutrient Supplement
Intervention Description
Iodine Containing Multiple Micronutrient Supplement once daily
Primary Outcome Measure Information:
Title
Visual Evoked Potentials
Description
P1 Latency
Time Frame
6 months post partum
Title
BMIC
Description
Breast Milk Iodine Concentration at 1 month
Time Frame
1 month post partum
Secondary Outcome Measure Information:
Title
EEG Fc
Description
EEG Functional Connectivity
Time Frame
6 months
Title
Infant HCAZ at 6 months
Description
Infant head circumference Z-score
Time Frame
6 months
Title
Infant UIC
Description
Infant Urine Iodine Concentration
Time Frame
6 months
Title
Infant Tg
Description
Dried blood spot thyroglobulin
Time Frame
6 months
Title
Infant TSH
Description
Thyroid Stimulating Hormone
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Lee, MD, MPH
Phone
6177328343
Email
alee6@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sylva Yeghiayan, PhD
Email
syeghiayan@bwh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment
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