Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT03027505
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4958}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery rate', 'timeFrame': 'Between 4 and 12 weeks', 'description': 'The recovery is defined as below :\n\n* Minimum of 4 weeks of participation in the program\n* MUAC\\> = 125 mm on 2 consecutive visits\n* No edema for minimum 2 weeks\n* Good Clinical Health'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': 'Between inclusion and week 12'}, {'measure': 'Default rate', 'timeFrame': 'Between 3 and 12 weeks', 'description': 'Patient absent for 3 consecutive visits'}, {'measure': 'Non-respondent rate', 'timeFrame': '12 weeks after inclusion', 'description': 'Patient who not reach the recovery criteria after twelve weeks in the program'}, {'measure': 'Hospitalization rate', 'timeFrame': 'Between inclusion and week 12'}, {'measure': 'Relapse rate', 'timeFrame': 'up to 3 months', 'description': "Patient having reached the recovery criteria and returning for a new episode of malnutrition (MUAC\\<125mm).\n\nThe children's MUAC will be measured at home 3 months after program exit. For organizational and financial reasons, this data will not be collected for all children. A specific protocol explaining the sampling and organization of data collection will be annexed to the protocol."}, {'measure': 'RUTF rations', 'timeFrame': 'Between inclusion and week 12', 'description': 'Total number of RUTF bags received per child during participation in the program.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MUAC', 'Acute malnutrition', 'RUTF', 'Children', 'Burkina Faso'], 'conditions': ['Global Acute Malnutrition (GAM)']}, 'descriptionModule': {'briefSummary': "MUAC only is a pilot trial external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso.\n\nThe objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. The hypotheses of the integrated protocol include :\n\n1. A global treatment of acute malnutrition (moderate and severe) with a single treatment (RUTF) would improve the functioning of the program through early identification of acutely malnourished children, while achieving a better coverage and using a single supply chain.\n2. A gradual reduction of RUTF dosage according to a child's MUAC status could significantly increase the number of children on treatment without increasing overall RUTF quantity while maintaining similar recovery rates.", 'detailedDescription': "Objectives :\n\nMain objective :\n\nTo ensure the recovery rate of the integrated protocol for treatment of acute malnutrition is significantly greater than 75% (reference value of the national program in BF).\n\nSecondary objectives :\n\n* To ensure the mortality rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 3% (reference value of the national BF program).\n* To ensure the default rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15% (reference value of the national BF program).\n* To ensure the non-response rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 8%.\n* To ensure the hospitalization rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15%.\n* To ensure the coverage rate of the program increases by 30% after the year the integrated protocol was introduced (specific protocol annexed).\n* To estimate the relapse rate of the integrated protocol for treatment of acute malnutrition.\n* To compare RUTF rations per child of the integrated protocol compared to the national protocol\n\nMethods :\n\nThe study population will include all acutely malnourished children aged between 6 and 59 months seeking consultations at all of the health centers in Yako District between January 2017 and December 2017.\n\nThe study will be implemented in Burkina Faso's Yako District, which includes 54 health centers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being between 6 and 59 months old\n* New admission\n* Acute malnutrition defined as follows:\n\n * MUAC\\<125mm\n * MUAC\\> 125mm AND WHZ (Z-score) \\<-3 (WHO standard)\n * Edema\n* Resident in the study area (Yako district)\n* Signed informed consent of the mother or the child's guardian\n\nExclusion Criteria:\n\n* Children allergic to milk, peanuts and / or RUTF"}, 'identificationModule': {'nctId': 'NCT03027505', 'acronym': 'MUAC-Only', 'briefTitle': 'Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for International Medical Action'}, 'officialTitle': 'Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso', 'orgStudyIdInfo': {'id': 'MUAC Only Burkina Faso'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MUAC<125mm', 'description': 'no medical complication', 'interventionNames': ['Drug: Ready to Use Therapeutic Food (RUTF)']}], 'interventions': [{'name': 'Ready to Use Therapeutic Food (RUTF)', 'type': 'DRUG', 'otherNames': ['MUAC<125mm'], 'description': 'MUAC used as the primary admission and exit criteria for children with MUAC \\<125mm and no medical complication.\n\nSingle treatment of RUTF for severe and moderate malnourished children and gradual reduction of doses according to the MUAC and the weight of the child during treatment. MUAC split into 3 categories:\n\n* MUAC \\<115 mm: 175 kcal /kg/day\n* 115 \\<MUAC \\<120mm: 125kcal/kg/day\n* 120 \\<MUAC \\<125mm: 75kcal/kg/day', 'armGroupLabels': ['MUAC<125mm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yako', 'state': 'Nord Region', 'country': 'Burkina Faso', 'facility': 'ALIMA', 'geoPoint': {'lat': 12.9591, 'lon': -2.26075}}], 'overallOfficials': [{'name': 'Susan Shepherd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Directrice de recherches Opérationnelles et Médicales, ALIMA, USA'}, {'name': 'Renaud Becquet, MPH,PhD,HDR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chercheur Inserm, Inserm U1219 Bordeaux Population Health Center-Université de Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for International Medical Action', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Association Keoogo', 'class': 'UNKNOWN'}, {'name': 'Institut de Recherche en Sciences de la Sante, Burkina Faso', 'class': 'OTHER_GOV'}, {'name': 'SOS médecins Burkina Faso', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}