Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT01154595
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2010-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-10', 'studyFirstSubmitDate': '2010-06-29', 'studyFirstSubmitQcDate': '2010-06-30', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative wasting incidence, hemoglobin concentration', 'timeFrame': 'monthly'}], 'secondaryOutcomes': [{'measure': 'weight gain', 'timeFrame': 'monthly'}, {'measure': 'time to become wasted', 'timeFrame': 'monthly'}, {'measure': 'default rate', 'timeFrame': 'monthly'}, {'measure': 'RUF acceptability', 'timeFrame': 'monthly'}, {'measure': 'dietary intake', 'timeFrame': 'monthly'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['moderate acute malnutrition, prevention, Lipid-based supplement'], 'conditions': ['Child', 'Malnutrition']}, 'referencesModule': {'references': [{'pmid': '23028263', 'type': 'DERIVED', 'citation': 'Huybregts L, Houngbe F, Salpeteur C, Brown R, Roberfroid D, Ait-Aissa M, Kolsteren P. The effect of adding ready-to-use supplementary food to a general food distribution on child nutritional status and morbidity: a cluster-randomized controlled trial. PLoS Med. 2012;9(9):e1001313. doi: 10.1371/journal.pmed.1001313. Epub 2012 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* WH≥80% of median of NCHS reference without bilateral pitting oedema;\n* Age ≥ 6 months and ≤36 months;\n* Member of a household with a dependency ratio \\>4;\n* Not planning to leave the study zone for the coming 5 months;\n\nExclusion Criteria:\n\n* Not showing appetite;\n* Age \\< 6 months or age \\> 36 months\n* Weight-for-Height Z-score \\<-2 and/or the presence of bilateral pitting oedema in children 6-36 months;\n* Member of a household with a dependency ration ≤ 4;\n* Clinical complications\n* Presence of chronic illness, cardiac disease, congenital abnormalities, cancer;\n* Being allergic to one of the ingredients of the RUF.'}, 'identificationModule': {'nctId': 'NCT01154595', 'acronym': 'PREAMA', 'briefTitle': 'Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition', 'organization': {'class': 'OTHER', 'fullName': 'Action Contre la Faim'}, 'officialTitle': 'Effectiveness and Cost-effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Malnutrition in Children Between 6-36 Months in Urban Chad', 'orgStudyIdInfo': {'id': 'UGENT0410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Food-for-Training component', 'description': 'Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.', 'interventionNames': ['Behavioral: Food-for-Training']}, {'type': 'EXPERIMENTAL', 'label': 'Food-for-Training + RUF (Plumpy Doz(r))', 'description': 'Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.\n\nIn addition, a blanket supplementation with 47g RUF (Plumpy Doz(r)) per day per child is provided.', 'interventionNames': ['Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food', 'Behavioral: Food-for-Training']}], 'interventions': [{'name': 'Plumpy Doz(r) - Ready-to-Use Food', 'type': 'DIETARY_SUPPLEMENT', 'description': '47g Plumpy Doz(r) per day per child', 'armGroupLabels': ['Food-for-Training + RUF (Plumpy Doz(r))']}, {'name': 'Food-for-Training', 'type': 'BEHAVIORAL', 'description': 'Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.', 'armGroupLabels': ['Food-for-Training + RUF (Plumpy Doz(r))', 'Food-for-Training component']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abéché', 'country': 'Chad', 'facility': 'Action Contre La Faim Tchad', 'geoPoint': {'lat': 13.82916, 'lon': 20.8324}}], 'overallOfficials': [{'name': 'Patrick Kolsteren, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}, {'name': 'Lieven Huybregts, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Action Contre la Faim', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lieven Huybregts', 'investigatorAffiliation': 'University Ghent'}}}}