Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-05-01 @ 9:12 PM
Study NCT ID:
NCT02994212
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2016-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}], 'ancestors': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2016-12-13', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight gain', 'timeFrame': '4 weeks', 'description': 'grams/kilograms/day gained'}, {'measure': 'mid-upper arm circumference gain (mm/day)', 'timeFrame': '4 weeks', 'description': 'millimeters gained per day'}, {'measure': 'weight loss > 5%', 'timeFrame': '4 weeks'}, {'measure': 'development of edema', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'correct utilization of RUTF', 'timeFrame': '4 weeks', 'description': '\\> 2 sachets deviance between available and expected RUTF stocks at unannounced household visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Acute Malnutrition']}, 'referencesModule': {'references': [{'pmid': '28404577', 'type': 'DERIVED', 'citation': 'Isanaka S, Kodish SR, Berthe F, Alley I, Nackers F, Hanson KE, Grais RF. Outpatient treatment of severe acute malnutrition: response to treatment with a reduced schedule of therapeutic food distribution. Am J Clin Nutr. 2017 May;105(5):1191-1197. doi: 10.3945/ajcn.116.148064. Epub 2017 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. A reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot intervention study in which 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm circumference) MUAC gain, weight loss \\> 5%, and the development of edema. Unannounced household spot checks were conducted over 4 weeks to assess household utilization of RUTF and storage practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a) being eligible for new admission to treatment of uncomplicated SAM\n* b) being resident within 15 km of the study health center\n\nExclusion Criteria:\n\n* previously default from previous SAM treatment (e.g. missed 2 consecutive weekly visits)\n* considered a relapse case (e.g. re-admitted within three months of previous discharge)'}, 'identificationModule': {'nctId': 'NCT02994212', 'briefTitle': 'Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety', 'organization': {'class': 'OTHER', 'fullName': 'Epicentre'}, 'officialTitle': 'Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety', 'orgStudyIdInfo': {'id': '821414-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response.', 'interventionNames': ['Dietary Supplement: Monthly distribution of RUTF']}], 'interventions': [{'name': 'Monthly distribution of RUTF', 'type': 'DIETARY_SUPPLEMENT', 'description': '115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sheila Isanaka, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Epicentre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epicentre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Médecins Sans Frontières, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}