[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576178":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":47,"locations":56,"responsibleParty":69,"collaborators":72,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":34,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":114,"whyStopped":34,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"National Institute for Medical Research, Tanzania","OTHER_GOV",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"eRUTF","EXPERIMENTAL","Choline and DHA enriched Ready to use therapeutic foods",[13],"Dietary Supplement: Ready to Use Therapeutic Food (RUTF)",{"label":15,"type":16,"description":17,"interventionNames":18},"sRUTF","PLACEBO_COMPARATOR","Standard ready-to-use therapeutic foods",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"PS","Psychosocial stimulation",[23],"Behavioral: Psychosocial stimulation",{"label":25,"type":16,"description":26,"interventionNames":27},"sNC","Standard nutritional counseling and psychosocial stimualtion",[23],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIETARY_SUPPLEMENT","Ready to Use Therapeutic Food (RUTF)","DHA \\& Choline enriched RUTF The modified RUTF is a peanut butter paste that contains vegetable oil, skim milk powder, carbohydrates, vitamins, and minerals the same nutrients which are the same as the standard RUTF but is fortified additionally with 250 mg of choline and 200 mg of preformed DHA per 92-gram sachet.\n\nStandard RUTF The standard RUTF used in the BrightSAM trial is a peanut butter paste with vegetable oil, skim milk powder, carbohydrates, vitamins, and minerals that is intended to cover the child's total daily nutritional needs. Standard RUTF will be manufactured in compliance with the specifications recommended by the Codex Alimentarius Commission17.",[9,15],null,{"type":36,"name":21,"description":37,"armGroupLabels":38,"otherNames":34},"BEHAVIORAL","The psychosocial intervention has been developed and piloted for this study as a context-relevant adaptation from the WHO\u002FUNICEF Care for Child Development package. It will be delivered in group sessions, where the primary caregiver will attend along with the child participating in the trial.\n\nDuring seven sessions of approximately two hours, caregivers will be trained on a variety of subjects which include; the first four sessions will be introductory and provide the basics of nutrition, the basics of psychosocial stimulation, and play and communication practices. We will build on the increasing experience of the caregivers and provide a deeper understanding of early child development.\n\nStandard nutritional counseling will adhere to national guidelines for pediatric management of severe acute malnutrition including nutritional counseling and psychosocial stimulation.",[20,25],[40,44],{"name":41,"affiliation":42,"role":43},"Mette Olsen, MSc, PhD","Rigshospitalet, Denmark","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":43},"George PrayGod, MD, PhD","National Institute for Medical Research",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":34,"email":51},"CONTACT","+255714226305","george.praygod@nimr.or.tz",{"name":53,"role":49,"phone":54,"phoneExt":34,"email":55},"Belinda Kweka, MD, MSc","+255765025170","belinda.kweka@nimr.or.tz",[57],{"facility":46,"status":34,"city":58,"state":34,"zip":34,"country":59,"countryCode":34,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Mwanza","Tanzania",{"type":61,"coordinates":62},"Point",[63,64],32.9,-2.51667,{"lat":64,"lon":63},[67,68],{"name":45,"role":49,"phone":50,"phoneExt":34,"email":51},{"name":53,"role":49,"phone":54,"phoneExt":34,"email":55},{"type":43,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Dr George PrayGod","Chief Research Scientist",[73,76,79,81,82,84,86],{"name":74,"class":75},"University of Liverpool","OTHER",{"name":77,"class":78},"Bugando Medical Centre","UNKNOWN",{"name":80,"class":75},"University of Turku",{"name":42,"class":75},{"name":83,"class":75},"University of Copenhagen",{"name":85,"class":75},"Sokoine University of Agriculture",{"name":87,"class":75},"London School of Hygiene and Tropical Medicine","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":100,"type":101},800,"ESTIMATED","INTERVENTIONAL",[104],"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.",[107],"Severe Acute Malnutrition in Childhood",[109,110,111,21,112,113],"Severe acute malnutrition","Ready to use therapeutic food","Childhood development","Choline","Docosahexaenoic acid (DHA)","NOT_YET_RECRUITING","2025-01-13",{"date":117,"type":118},"2025-01-17","ACTUAL",{"date":120,"type":101},"2025-02-03",{"date":122,"type":101},"2026-05-14",{"name":5,"class":6},1]