search
Back to results

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
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iodine Deficiency

Eligibility Criteria

undefined - 2 Weeks (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 5, 2023
    Last Updated
    July 24, 2023
    Sponsor
    Brigham and Women's Hospital
    search

    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

    We'll reach out to this number within 24 hrs