[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508541":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":34,"collaborators":38,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":18,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":18,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":18,"overallStatus":71,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":18},{"fullName":5,"class":6},"Brown University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Iodine Containing Multiple Micronutrient (UNIMMAP)","EXPERIMENTAL","UNIMMAP 1 tablet po once daily from birth to 6 months postpartum",[13],"Dietary Supplement: UNIMMAP Multiple Micronutrient Supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Routine postnatal care","NO_INTERVENTION","Routine postnatal care per Ethiopian Ministry of Health guidelines",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","UNIMMAP Multiple Micronutrient Supplement","Iodine Containing Multiple Micronutrient Supplement once daily",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Anne Lee, MD, MPH","CONTACT","401-430-8015","anne_cc_lee@brown.edu",{"name":32,"role":28,"phone":18,"phoneExt":18,"email":33},"Kaitlin Mason, MPH, BSN","kaitlin_mason@brown.edu",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Anne Shee CC Lee","Levinger Family Professor of Pediatrics",[39,41,43,45,47],{"name":40,"class":6},"Addis Continental Institute of Public Health",{"name":42,"class":6},"Brigham and Women's Hospital",{"name":44,"class":6},"Johns Hopkins Bloomberg School of Public Health",{"name":46,"class":6},"University of South Carolina",{"name":48,"class":6},"Boston Children's Hospital","100508541","phase-4-effect-of-iodine-containing-multiple-micronutrient-during-lactation-on-infant-neurodevelopment-100508541",false,"NCT05901766","Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment","Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment","To be eligible, women will be required to meet the following inclusion criteria:\n\n* Maternal age 18 years or above, singleton pregnancy,\n* data available on Last Menstrual Period (LMP) or early ultrasound,\n* Intention to exclusively feed breastmilk for 4 to 6 months,\n* Intention to stay in the study catchment area for at least 6 months,\n* Willingness to take a daily supplement of MMS for 6 months\n\nExclusion criteria include:\n\n* Severe maternal morbidity (postpartum eclampsia, postpartum hemorrhage),\n* Maternal condition leading to inability for infant to directly\u002Fexclusively breastfeed (maternal mastectomy, or other breast surgery),\n* Breast cancer,\n* Tuberculosis",true,"FEMALE","18 Years",{"count":60,"type":61},600,"ESTIMATED","INTERVENTIONAL",[64],"PHASE4","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\u002Fvisual 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.",[67,68,69,70],"Iodine Deficiency","Nutrition Poor","Development, Infant","Breastfeeding","NOT_YET_RECRUITING","2026-05-21",{"date":74,"type":75},"2026-05-26","ACTUAL",{"date":77,"type":61},"2026-05-01",{"date":79,"type":61},"2028-03-31",{"name":5,"class":6}]