[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute for Medical Research, Tanzania\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100576178","phase-3-severe-acute-malnutrition-and-child-development-clinical-trial-in-mwanza-100576178",false,"NCT06781918","Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza","BRAIN DEVELOPMENT, GROWTH AND HEALTH IN CHILDREN WITH SEVERE ACUTE MALNUTRITION","BRIGHTSAM","Inclusion Criteria:\n\n1. Age from 6-36 months.\n2. Consent given by a caregiver older than 18 years.\n3. Diagnosed with severe acute malnutrition (MUAC\\<115 mm, or WHZ ≤-3 or bipedal pitting edema).\n4. Eligible for RUTF treatment (expanded below).\n\nExclusion Criteria:\n\n1. Conditions preventing the child from receiving interventions, e.g., peanut butter allergy or cleft palate.\n2. Moderate or severe disability which significantly affects normal child development (e.g., cerebral palsy or hydrocephalus), identified using a standardized screening form.\n3. Children of families not living in the area or planning to move from the area within the follow-up period","ALL","6 Months","36 Months",{"count":21,"type":22},800,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a randomized clinical trial to learn whether ready-to-use therapeutic foods enriched with choline and docosahexaenoic acid (DHA) together with psychosocial stimulating activities work well to improve child development in children with severe acute malnutrition(SAM). The overall question this trial aims to answer is can the health and development outcomes of children with SAM be improved through optimized nutritional treatment and integrated psychosocial support.\n\nResearchers will compare the new ready-to-use therapeutic food and an integrated psychosocial stimulation to a standard look-alike nutritional supplement that contains no additional nutrients being investigated and the standard nutritional counseling given locally and assess its effects on child development in children with severe acute malnutrition.\n\nParticipants will:\n\n* Be given the trial interventions which will be delivered over 12 weeks\n* After the 12 weeks of intervention, participants will return for outcome evaluations (week 12 study visit), which will be repeated at follow-up visits after 24 and 48 weeks.",[28],"Severe Acute Malnutrition in Childhood",[30,31,32,33,34,35],"Severe acute malnutrition","Ready to use therapeutic food","Childhood development","Psychosocial stimulation","Choline","Docosahexaenoic acid (DHA)","NOT_YET_RECRUITING","2025-01-13",{"date":39,"type":40},"2025-01-17","ACTUAL",{"date":42,"type":22},"2025-02-03",{"date":44,"type":22},"2026-05-14",{"name":46,"class":47},"National Institute for Medical Research, Tanzania","OTHER_GOV",""]