Menu
Not yet recruiting NCT05901766

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

Phase IV Interventional Iodine Deficiency Nutrition Poor Development, Infant Breastfeeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UNIMMAP Multiple Micronutrient Supplement.
Who it may be relevant to
Registry conditions: Iodine Deficiency, Nutrition Poor, Development, Infant, Breastfeeding. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Dietary supplement UNIMMAP Multiple Micronutrient Supplement
    Iodine Containing Multiple Micronutrient Supplement once daily

Primary outcome measures

  • EEG Power [Time frame: 6 months]
Secondary outcome measures (12)
  • EEG Fc [Time frame: 6 months]
  • BMIC [Time frame: 3 month post partum]
  • Visual Evoked Potentials [Time frame: 6 months post partum]
  • Infant HCAZ at 6 months [Time frame: 6 months]
  • Infant UIC [Time frame: 6 months]
  • Infant Tg [Time frame: 3 months]
  • Infant TSH [Time frame: 3 months]
  • Neuromotor response [Time frame: 3 months]
  • Neuromotor response [Time frame: 6 months]
  • Global development [Time frame: 6 months]
  • Eye Tracking [Time frame: 6 months]
  • Breast milk B vitamin concentration [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05901766 · 2021P002634

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗