Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT00819858
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2009-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D003289', 'term': 'Convalescence'}, {'id': 'D008288', 'term': 'Malaria'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-15', 'studyFirstSubmitDate': '2009-01-08', 'studyFirstSubmitQcDate': '2009-01-08', 'lastUpdatePostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight gain', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'weight gain', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['weight loss', 'weight gain', 'malnutrition', 'convalescence', 'malaria', 'RUTF', 'RUF', 'supplementation', 'nutrition'], 'conditions': ['Weight Loss', 'Weight Gain', 'Convalescence', 'Malaria']}, 'referencesModule': {'references': [{'pmid': '22558108', 'type': 'DERIVED', 'citation': 'van der Kam S, Swarthout T, Niragira O, Froud A, Sompwe EM, Mills C, Roll S, Tinnemann P, Shanks L. Ready-to-use therapeutic food for catch-up growth in children after an episode of Plasmodium falciparum malaria: an open randomised controlled trial. PLoS One. 2012;7(4):e35006. doi: 10.1371/journal.pone.0035006. Epub 2012 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine to what extent provision with RUTF will promote catch up growth in children following an acute uncomplicated episode of P. falciparum malaria.', 'detailedDescription': 'Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection.\n\nChildren aged 6-59 months presenting with malaria caused by P. falciparum who are provided with a RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks will show significantly better catch up growth compared to a similar patient group not provided with RUTF (at 2 weeks and 4 weeks post-intervention).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6 to 59 months, and\n* Positive rapid diagnostic test (Paracheck®) and\n* Thick smear showing infection with P. falciparum and\n* Informed consent from parents or guardian aged at least 18 years.\n\nExclusion Criteria:\n\n* Children who are exclusively breast fed or\n* Children who are severely malnourished (MUAC \\<110 mm and/or bilateral oedema, or WHO weight-for-Height criteria \\<3 Z-scores) or\n* Presence of general danger signs or signs of severe malaria as defined by the WHO criteria, or\n* Known history of allergy to malaria drugs, or\n* Having a sibling enrolled in the study.'}, 'identificationModule': {'nctId': 'NCT00819858', 'briefTitle': 'Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight', 'organization': {'class': 'OTHER', 'fullName': 'Medecins Sans Frontieres, Netherlands'}, 'officialTitle': 'The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria', 'orgStudyIdInfo': {'id': 'MSF-nutcon01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RUTF', 'description': 'RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks', 'interventionNames': ['Dietary Supplement: RUTF (Plumpynut®)']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no supplement given'}], 'interventions': [{'name': 'RUTF (Plumpynut®)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['RUTF', 'Ready to use Therapeutic Food', 'RUF', 'Lipid based food supplement'], 'description': 'Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement', 'armGroupLabels': ['RUTF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dubie', 'state': 'Katanga', 'country': 'Republic of the Congo', 'facility': 'Central Hospital'}], 'overallOfficials': [{'name': 'Saskia van der Kam, Ir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'nutrition expert MSF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medecins Sans Frontieres, Netherlands', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ir', 'investigatorFullName': 'Saskia van der Kam', 'investigatorAffiliation': 'Medecins Sans Frontieres, Netherlands'}}}}