[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576982":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":67,"centralContacts":68,"locations":78,"responsibleParty":98,"collaborators":100,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":67,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":134,"whyStopped":67,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Institut de Recherche en Sciences de la Sante, Burkina Faso","OTHER_GOV",[8,14,20,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"MAM RUTF","EXPERIMENTAL","Participants with MAM in this arm will receive a dose of 500 kcal\u002Fkg\u002Fday of RUTF",[13],"Dietary Supplement: ready-to-use therapeutic food (for children with MAM)",{"label":15,"type":16,"description":17,"interventionNames":18},"MAM RUSF","ACTIVE_COMPARATOR","Participants with MAM in this arm will receive a dose of 540 kcal\u002Fkg\u002Fday of RUSF",[19],"Dietary Supplement: Ready-to-use supplementary food",{"label":21,"type":10,"description":22,"interventionNames":23},"SAM Reduced-dose RUTF 1 (R-RUTF 1)","Participants with SAM in this arm will receive a dose of 150-185 kcal\u002Fkg\u002Fday of RUTF until programmatic recovery",[24],"Dietary Supplement: Ready to Use Therapeutic Food - Reduced dose 1",{"label":26,"type":10,"description":27,"interventionNames":28},"SAM Reduced-dose RUTF 2 (R-RUTF 2)","Participants with SAM in this arm will receive a dose of 150-185 kcal\u002Fkg\u002Fday of RUTF until the child is no longer severely malnourished and does not have nutritional oedema then 100-130 kcal\u002Fkg\u002Fday of RUTF until programmatic recovery",[29],"Dietary Supplement: Ready to Use Therapeutic Food - Reduced dose 2",{"label":31,"type":16,"description":32,"interventionNames":33},"SAM standard dose RUTF (S-RUTF)","Participants with SAM in this arm will receive the standard dose of RUTF according to the national protocol for the integrated management of acute malnutrition in Burkina Faso",[34],"Dietary Supplement: Ready to Use Therapeutic Food - Standard dose",[36,43,49,55,61],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DIETARY_SUPPLEMENT","ready-to-use therapeutic food (for children with MAM)","Each child with MAM will be supplemented with RUTF for a maximum of 12 weeks. He\u002Fshe will be followed subsequently up to 24 weeks.",[9],[42],"RUTF",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Ready-to-use supplementary food","Each child with MAM will be supplemented with RUSF for a maximum of 12 weeks. He\u002Fshe will be followed subsequently up to 24 weeks post recovery",[15],[48],"RUSF",{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Ready to Use Therapeutic Food - Reduced dose 1","Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal\u002Fkg\u002Fday of RUTF until programmatic recovery. He\u002Fshe will be followed subsequently up to 24 weeks post recovery.",[21],[54],"R-RUTF 1",{"type":37,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Ready to Use Therapeutic Food - Standard dose","Each child with SAM will be treated with a standard dose (according to the national protocol for the integrated management of acute malnutrition in Burkina Faso) for a maximum of 12 weeks. He\u002Fshe will be followed subsequently up to 24 weeks post recovery.",[31],[60],"S-RUTF",{"type":37,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Ready to Use Therapeutic Food - Reduced dose 2","Each child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal\u002Fkg\u002Fday of RUTF until the child is no longer severely malnourished and does not have nutritional oedema then 100-130 kcal\u002Fkg\u002Fday of RUTF until programmatic recovery. He\u002Fshe will be followed subsequently up to 24 weeks post recovery.",[26],[66],"R-RUTF 2",null,[69,74],{"name":70,"role":71,"phone":72,"phoneExt":67,"email":73},"Hermann Biènou LANOU, MD., PhD","CONTACT","+226 66557580","hlanou@yahoo.ca",{"name":75,"role":71,"phone":76,"phoneExt":67,"email":77},"Seni KOUANDA, MD., PhD","+226 70261462","senikouanda@gmail.com",[79],{"facility":80,"status":67,"city":81,"state":82,"zip":67,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Institut de Recherche en Sciences de la Santé","Ouagadougou","KADIOGO","Burkina Faso","BF",{"type":86,"coordinates":87},"Point",[88,89],-1.53388,12.36566,{"lat":89,"lon":88},[92,93,94,96],{"name":70,"role":71,"phone":72,"phoneExt":67,"email":73},{"name":75,"role":71,"phone":67,"phoneExt":67,"email":67},{"name":95,"role":71,"phone":67,"phoneExt":67,"email":67},"Hermann Bienou LANOU, MD., PhD",{"name":97,"role":71,"phone":67,"phoneExt":67,"email":67},"Jerome W. SOME, MD., PhD",{"type":99,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR",[101],{"name":102,"class":103},"Bill and Melinda Gates Foundation","OTHER","100576982","effectiveness-of-an-alternative-protocol-in-the-management-of-acute-malnutrition-100576982",false,"NCT06792370","Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition","Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition in Children Aged 6-59 Months in Burkina Faso: Reduced Dose of RUTF for SAM Children and RUTF Instead of RUSF for MAM Children","Alternat-MAL","1. MAM\n\n   Inclusion Criteria:\n   * Anthropometric measures:\n\n     * (115 mm ≤ MUAC\\\u003C 125 mm and -3 SDs ≤ WLZ \\\u003C -2 SDs) OR\n     * (115 mm ≤ MUAC\\\u003C 125 mm and WLZ ≥ -2 SDs) OR\n     * (MUAC ≥ 125 mm and -3 SDs ≤ WLZ \\\u003C -2 SDs).\n   * Age: 6 to 59 months\n   * Parents' acceptance of biweekly visits until programme discharge and monthly visits for the post-programme follow up\n\n   Exclusion Criteria:\n   * Failure of appetite test\n   * Medical complications requiring hospital treatment\n   * Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection\n   * Presence of bilateral oedema\n   * History of allergies to peanuts, milk, or soya\n   * Relapse from MAM treatment or transfer from SAM treatment\n   * Children who have recently (\\\u003C2 months) taken part in a nutrition programme;\n   * Residence outside the study area\n   * Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)\n2. SAM\n\nInclusion Criteria:\n\n* Anthropometric measures MUAC\\\u003C 115 mm or WLZ\\\u003C - 3 SDs;\n* Age: 6-59 months;\n* Parents' acceptance of weekly visits until programme discharge and monthly visits for the post-programme follow up.\n\nExclusion Criteria:\n\n* Failure of appetite test\n* Medical complications requiring hospital treatment\n* Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection\n* Presence of bilateral oedema\n* History of allergies to peanuts, milk or soya\n* Relapse from MAM treatment or transfer from SAM treatment\n* Children who have recently (\\\u003C2 months) taken part in a nutrition programme;\n* Residence outside the study area;\n* Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)","ALL","6 Months","59 Months",{"count":116,"type":117},3521,"ESTIMATED","INTERVENTIONAL",[120],"NA","This experimental study aims to test an alternative protocol for managing acute malnutrition in children aged 6-59 months in Burkina Faso. This alternative protocol consists of using RUTF instead of RUSF for the management of moderate acute malnutrition and reduced-dose RUTF instead of standard-dose RUTF for the treatment of severe acute malnutrition.\n\nThe main questions are:\n\n1. Does treating children with moderate acute malnutrition using RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with RUSF?\n2. Does treating children with uncomplicated severe acute malnutrition using a reduced dose of RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with a standard dose of RUFT?\n\nSecondly, the study will investigate the effect of this alternative protocol compared to the standard protocol on cost-effectiveness, psychomotor development, weight and linear growth and incidence of relapses.",[123],"Acute Malnutrition with No Complications",[125,126,127,128,129,130,131,132,133],"Effectiveness","acute malnutrition","management","treatment","reduced dose","Ready-to-Use Supplementary Foods","Ready-to-Use Therapeutic Foods","uncomplicated","without complication","NOT_YET_RECRUITING","2025-01-20",{"date":137,"type":138},"2025-01-24","ACTUAL",{"date":140,"type":117},"2025-05",{"date":142,"type":117},"2026-12",{"name":5,"class":6},1]