Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-03 @ 1:46 AM
Study NCT ID:
NCT05901766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2023-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individually randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2023-06-05', 'studyFirstSubmitQcDate': '2023-06-05', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Evoked Potentials', 'timeFrame': '6 months post partum', 'description': 'P1 Latency'}, {'measure': 'BMIC', 'timeFrame': '1 month post partum', 'description': 'Breast Milk Iodine Concentration at 1 month'}], 'secondaryOutcomes': [{'measure': 'EEG Fc', 'timeFrame': '6 months', 'description': 'EEG Functional Connectivity'}, {'measure': 'Infant HCAZ at 6 months', 'timeFrame': '6 months', 'description': 'Infant head circumference Z-score'}, {'measure': 'Infant UIC', 'timeFrame': '6 months', 'description': 'Infant Urine Iodine Concentration'}, {'measure': 'Infant Tg', 'timeFrame': '6 months', 'description': 'Dried blood spot thyroglobulin'}, {'measure': 'Infant TSH', 'timeFrame': '6 months', 'description': 'Thyroid Stimulating Hormone'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iodine Deficiency', 'Nutrition Poor', 'Development, Infant', 'Breastfeeding']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n1. What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials?\n2. What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status?\n3. How do iodine and iron interact with each other to affect thyroid function in the mother during lactation?\n\nParticipants 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.\n\nResearchers 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intention to breast feed at least 3 months\n* Birth weight \\>2000g\n\nExclusion Criteria:\n\n* Intention to primarily feed by alternative sources (formula, animal milk)\n* Multiple pregnancy\n* Infant with major congenital anomalies\n* Infants with severe morbidity or developmental disorder\n* Mother with HIV or chronic renal disease\n* Plan to move out of study catchment area\n* Does not agree to follow up or EEG/VEP'}, 'identificationModule': {'nctId': 'NCT05901766', 'briefTitle': 'Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment', 'orgStudyIdInfo': {'id': '2021P002634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iodine Containing Multiple Micronutrient (UNIMAP)', 'description': 'UNIMAP 1 tablet po once daily from birth to 6 months postpartum', 'interventionNames': ['Dietary Supplement: UNIMAP Multiple Micronutrient Supplement']}, {'type': 'NO_INTERVENTION', 'label': 'Routine postnatal care', 'description': 'Routine postnatal care per Ethiopian Ministry of Health guidelines'}], 'interventions': [{'name': 'UNIMAP Multiple Micronutrient Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Iodine Containing Multiple Micronutrient Supplement once daily', 'armGroupLabels': ['Iodine Containing Multiple Micronutrient (UNIMAP)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Anne Lee, MD, MPH', 'role': 'CONTACT', 'email': 'anne_cc_lee@brown.edu', 'phone': '401-430-8015'}, {'name': 'Kaitlin Mason, MPH, BSN', 'role': 'CONTACT', 'email': 'kaitlin_mason@brown.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Addis Continental Institute of Public Health', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, {'name': 'University of South Carolina', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Levinger Family Professor of Pediatrics', 'investigatorFullName': 'Anne Shee CC Lee', 'investigatorAffiliation': 'Brown University'}}}}