[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582940":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":51,"locations":59,"responsibleParty":143,"collaborators":145,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":158,"sex":164,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":28,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":179,"overallStatus":62,"whyStopped":28,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"MFGM-RUTF (Milk fat globule membrane ready-to-use therapeutic food)","EXPERIMENTAL","One sachet contains 92g of MFGM-RUTF. During SAM treatment, each participant will be given sufficient MFGM-RUTF to consume 2 sachets per day, which will provide approximately 1000 calories, 27g of protein, 63g of fat, and over 1 RDA of micronutrients.",[13,14,15],"Dietary Supplement: MFGM-RUTF (milk fat globule membrane ready-to-use therapeutic food)","Drug: Amoxicillin","Drug: Sulfadoxine (12.5 mg)\u002FPyrimethamine (250 mg)",{"label":17,"type":18,"description":19,"interventionNames":20},"S-RUTF (standard ready-to-use therapeutic food)","ACTIVE_COMPARATOR","One sachet contains 92g of S-RUTF. During SAM treatment, each participant will be given sufficient S-RUTF to consume 2 sachets per day, which will provide approximately 1000 calories, 27g of protein, 60g of fat, and over 1 RDA of micronutrients.",[21,14,15],"Dietary Supplement: S-RUTF (standard ready-to-use therapeutic food)",[23,29,32,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIETARY_SUPPLEMENT","MFGM-RUTF (milk fat globule membrane ready-to-use therapeutic food)","MFGM whey protein\u002Ffat concentrate powder used in place of skim milk powder in peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications. There will be 10g of MFGM-containing whey protein\u002Ffat concentrate powder per 100g of MFGM-RUTF. Other ingredients and amounts per 100g: 9.5g rice flour, 5g whey permeate, 18.5g palm oil, 31g peanut paste, 22.1g sugar, 2.9g micronutrient mix, 1g fish oil.",[9],null,{"type":24,"name":17,"description":30,"armGroupLabels":31,"otherNames":28},"Standard peanut paste-based ready-to-use therapeutic food made with skim milk powder meeting Codex Alimentarius specifications. This RUTF is modeled on the most widely used recipe worldwide, containing per 100g: 19.5g skim milk powder, 9.3g palm oil, 7g canola oil, 31.3g peanut paste, 28g sugar, 1g soy flakes, 1g hydrogenated vegetable oil, and 2.9g micronutrient mix.",[17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"DRUG","Amoxicillin","Oral amoxicillin tablets twice per day for 7 days dosed based on weight",[9,17],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Sulfadoxine (12.5 mg)\u002FPyrimethamine (250 mg)","Malaria chemoprophylaxis, dosed by weight, to be given every month during SAM treatment",[9,17],[42,45,47],{"name":43,"affiliation":5,"role":44},"Mark J Manary, MD","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":5,"role":44},"Kevin B Stephenson, MD",{"name":48,"affiliation":49,"role":50},"Indi Trehan, MD, MPH","University of Washington","STUDY_DIRECTOR",[52,56],{"name":43,"role":53,"phone":54,"phoneExt":28,"email":55},"CONTACT","+1 314-454-2341","manarymj@wustl.edu",{"name":46,"role":53,"phone":57,"phoneExt":28,"email":58},"+1-314-749-8849","k.stephenson@wustl.edu",[60,77,86,90,94,103,112,116,125,134],{"facility":61,"status":62,"city":61,"state":63,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Bandajuma","RECRUITING","Pujehun","Sierra Leone","SL",{"type":67,"coordinates":68},"Point",[69,70],-10.49845,8.32207,{"lat":70,"lon":69},[73],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},"Ibrahim A Bangura","+232-77-330360","affieibrahim@gmail.com",{"facility":78,"status":62,"city":78,"state":63,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Bandasuma",{"type":67,"coordinates":80},[81,82],-10.71341,8.52295,{"lat":82,"lon":81},[85],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},{"facility":87,"status":62,"city":87,"state":63,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":28,"geoPoint":28,"contacts":88},"Bendu Malen",[89],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},{"facility":91,"status":62,"city":91,"state":63,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":28,"geoPoint":28,"contacts":92},"Gbondapi",[93],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},{"facility":95,"status":62,"city":95,"state":63,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Jendema",{"type":67,"coordinates":97},[98,99],-11.38527,7.02368,{"lat":99,"lon":98},[102],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},{"facility":104,"status":62,"city":104,"state":63,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Potoru",{"type":67,"coordinates":106},[107,108],-11.47897,7.50596,{"lat":108,"lon":107},[111],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},{"facility":113,"status":62,"city":113,"state":63,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":28,"geoPoint":28,"contacts":114},"Sahn Malen",[115],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},{"facility":117,"status":62,"city":117,"state":63,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Taninahun",{"type":67,"coordinates":119},[120,121],-11.4314,8.50816,{"lat":121,"lon":120},[124],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},{"facility":126,"status":62,"city":126,"state":63,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Zimmi",{"type":67,"coordinates":128},[129,130],-11.30818,7.31356,{"lat":130,"lon":129},[133],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},{"facility":135,"status":62,"city":63,"state":28,"zip":28,"country":64,"countryCode":65,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Static",{"type":67,"coordinates":137},[138,139],-11.72083,7.35806,{"lat":139,"lon":138},[142],{"name":74,"role":53,"phone":75,"phoneExt":28,"email":76},{"type":144,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[146,148,151,154],{"name":147,"class":6},"Project Peanut Butter",{"name":149,"class":150},"Ministry of Health and Sanitation, Sierra Leone","OTHER_GOV",{"name":152,"class":153},"Arla Foods","INDUSTRY",{"name":155,"class":6},"The Danish Dairy Research Foundation, Denmark","100582940","milk-fat-globule-membrane-enhanced-rutf-for-children-with-severe-acute-malnutrition-100582940",false,"NCT06869850","Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition","MFGM-EnhaNceD RUTF for Children With SAM","MEND-SAM","Inclusion Criteria:\n\n* 6-59 months of age\n* Reside within the catchment area of a participating clinic\n* mid-upper arm circumference \\\u003C 11.5 cm and\u002For weight-for-length z-score \\\u003C -3 and\u002For presence of bilateral pedal pitting edema\n* willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic\n\nExclusion Criteria:\n\n* Features of complicated SAM: inability to tolerate a 30 g test dose of RUTF, breathing difficulties, mental status changes, sepsis, diarrhea with severe dehydration, and\u002For physician\u002Fnursing clinical assessment that the child needs immediate hospitalization\n* Participation in a separate therapeutic feeding program within the past month\n* Known allergy to study food ingredient (peanut, milk, fish)\n* Clinically evident developmental delay (most often determined based on research nursing assessment of physical appearance, movement, and informal discussion with caregiver)\n* Presence of a chronic severe medical condition (other than tuberculosis and HIV), such as congenital heart disease","ALL","6 Months","59 Months",{"count":168,"type":169},1600,"ESTIMATED","INTERVENTIONAL",[172],"NA","The goal of this clinical trial is to test the use of milk fat globule membrane (MFGM) in ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition in Sierra Leone. The main questions it aims to answer are:\n\n* Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition improve their neurodevelopment?\n* Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition reduce its worst consequences: death, hospitalization, and remaining severely malnourished despite treatment?\n\nResearchers will compare the MFGM-containing RUTF to standard RUTF, which contains skim milk powder.\n\nParticipants will:\n\n* undergo measurement of length, weight, mid-upper arm circumference, and nutritional edema assessment every two weeks during severe malnutrition treatment\n* be treated with either MFGM-RUTF or standard RUTF at a dose of 2 sachets per day for up to 12 weeks\n* undergo neurodevelopmental testing using the Malawi Developmental Assessment Tool at the end of SAM treatment and 6 months later\n* a subset of participants will undergo blood spot collection and stool sample collection",[175,176,177,178],"Severe Acute Malnutrition","Cognitive Impairment","Kwashiorkor","Severe Wasting",[180,181,182,183,184,185,186,187,188,64,189],"severe acute malnutrition","severe wasting","kwashiorkor","milk fat globule membrane","neurodevelopment","phospholipids","ganglioside","dairy fat","malawi developmental assessment tool","ready-to-use therapeutic food","2025-12-16",{"date":192,"type":193},"2025-12-17","ACTUAL",{"date":195,"type":193},"2025-09-22",{"date":197,"type":169},"2027-12-01",{"name":5,"class":6},10]