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NCT Number: NCT05901766

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

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Key information

Conditions

Iodine Deficiency Behavior Breast Feeding Breastfeeding Development, Infant Feeding Behavior Malnutrition Nutrition Disorders Nutrition Poor Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UNIMMAP Multiple Micronutrient Supplement

Dietary Supplement

Iodine Containing Multiple Micronutrient Supplement once daily

Primary outcomes

  1. EEG Power

    Time frame: 6 months

    Absolute power of the alpha band

Secondary outcomes

  1. EEG Fc

    Time frame: 6 months

    EEG Functional Connectivity

  2. BMIC

    Time frame: 3 month post partum

    Breast Milk Iodine Concentration at 3 month

  3. Visual Evoked Potentials

    Time frame: 6 months post partum

    P1 Latency

  4. Infant HCAZ at 6 months

    Time frame: 6 months

    Infant head circumference Z-score

  5. Infant UIC

    Time frame: 6 months

    Infant Urine Iodine Concentration

  6. Infant Tg

    Time frame: 3 months

    Dried blood spot thyroglobulin

  7. Infant TSH

    Time frame: 3 months

    Thyroid Stimulating Hormone

  8. Neuromotor response

    Time frame: 3 months

    Generalized movement assessment (GMA)

  9. Neuromotor response

    Time frame: 6 months

    Hammersmith Infant Neurological Examination (HINE)

  10. Global development

    Time frame: 6 months

    Global Scales for Early Development (GSED)

  11. Eye Tracking

    Time frame: 6 months

    Cecile and MAAP visual attention tasks

  12. Breast milk B vitamin concentration

    Time frame: 6 months

    Breastmilk B-complex vitamin concentration

  13. Maternal anemia

    Time frame: 6 months

    Maternal hemoglobin

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Lee, MD, MPH

CONTACT

[email protected]

401-430-8015

Kaitlin Mason, MPH, BSN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 13, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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