Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT01593969
Status:
COMPLETED
Last Update Posted:
2014-08-18
First Post:
2012-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-15', 'studyFirstSubmitDate': '2012-05-04', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total long chain PUFA in erythrocyte membranes at 3 months', 'timeFrame': '3 months', 'description': 'Total long chain PUFA in erythrocyte membranes at 3 months'}], 'secondaryOutcomes': [{'measure': 'Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months', 'timeFrame': '3 months', 'description': 'Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months'}, {'measure': 'Total long chain PUFA in CD3 cell membranes at 3 months', 'timeFrame': '3 months', 'description': 'Total long chain PUFA in CD3 cell membranes at 3 months'}, {'measure': 'Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months', 'timeFrame': '3 months', 'description': 'Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months'}, {'measure': 'Total long chain PUFA in plasma at 3 months', 'timeFrame': '3 months', 'description': 'Total long chain PUFA in plasma at 3 months'}, {'measure': 'Ratio of n-6:n-3 PUFA in plasma at 3 months', 'timeFrame': '3 months', 'description': 'Ratio of n-6:n-3 PUFA in plasma at 3 months'}, {'measure': 'Change in weight for height z score between baseline and 3 months', 'timeFrame': '3 months', 'description': 'Change in weight for height z score between baseline and 3 months'}, {'measure': 'Change in mid upper arm circumference between baseline and 3 months', 'timeFrame': '3 months', 'description': 'Change in mid upper arm circumference between baseline and 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Essential Fatty Acid', 'Seed oil', 'Fish oil', 'Dietary deficiency'], 'conditions': ['Severe Acute Malnutrition']}, 'referencesModule': {'references': [{'pmid': '25902844', 'type': 'DERIVED', 'citation': 'Jones KD, Ali R, Khasira MA, Odera D, West AL, Koster G, Akomo P, Talbert AW, Goss VM, Ngari M, Thitiri J, Ndoro S, Knight MA, Omollo K, Ndungu A, Mulongo MM, Bahwere P, Fegan G, Warner JO, Postle AD, Collins S, Calder PC, Berkley JA. Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial. BMC Med. 2015 Apr 23;13:93. doi: 10.1186/s12916-015-0315-6.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition. The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.', 'detailedDescription': 'Randomized controlled trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Severe Malnutrition.\n\nDescription of Study Design: Randomized Controlled Trial\n\nStudy Duration: 6 months (Trial); 12 months (All trial-related activities)\n\nDescription of Intervention: Provision of ready to use food (RUTF) enriched with flax seed oil, with or without fish oil, compared to conventional-composition RUTF. Interventional product will be given until nutritional recovery to a maximum of 12 weeks.\n\nDesign: Flax-enriched or standard RUTF allocation is randomised and double blind. Fish oil allocation is randomised within those receiving flax-enriched RUTF and is open label.\n\nLocation: Kilifi District, coastal Kenya.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6 months to 5 years old\n* Provision of informed consent\n* Severe malnutrition (one or more of mid-upper arm circumference \\<11.5cm, weight for height z score \\<-3, or nutritional oedema)\n* Stabilised and eligible to receive RUTF according to national guidelines\n\nExclusion Criteria:\n\n* Known HIV disease, tuberculosis or other chronic infection\\*\n* Known allergy or hypersensitivity to any of the product ingredients\n\n * Chronic infections such as HIV and tuberculosis and their treatments are likely to cause alterations in lipid metabolism that may confound interpretation of this pilot trial. national guidelines recommend offering provider-initiated testing for HIV for all severely malnourished children, and referral for comprehensive care in the case of a positive test.'}, 'identificationModule': {'nctId': 'NCT01593969', 'acronym': 'Njugu Plus', 'briefTitle': 'A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition', 'orgStudyIdInfo': {'id': 'SSC 2157'}, 'secondaryIdInfos': [{'id': 'OPP1046183', 'type': 'OTHER_GRANT', 'domain': 'The Bill & Melinda Gates Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard RUTF', 'description': 'Standard RUTF given according to National Guidelines', 'interventionNames': ['Dietary Supplement: Standard RUTF']}, {'type': 'EXPERIMENTAL', 'label': 'RUTF/Flax Oil', 'description': 'RUTF/Flax Oil is reformulated RUTF to increase n3 content', 'interventionNames': ['Dietary Supplement: RUTF/Flax Oil']}, {'type': 'EXPERIMENTAL', 'label': 'RUTF/Flax Oil plus additional Fish Oil', 'description': 'RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3. Fish oil to provide long chain n3', 'interventionNames': ['Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil']}], 'interventions': [{'name': 'RUTF/Flax Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ready to Use Therapeutic Food', 'armGroupLabels': ['RUTF/Flax Oil']}, {'name': 'RUTF/Flax Oil plus additional Fish Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ready to Use Therapeutic Food', 'armGroupLabels': ['RUTF/Flax Oil plus additional Fish Oil']}, {'name': 'Standard RUTF', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Standard formulation RUTF given according to National Guidelines', 'armGroupLabels': ['Standard RUTF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80108', 'city': 'Kilifi', 'state': 'Coast', 'country': 'Kenya', 'facility': 'Kilifi District Hospital', 'geoPoint': {'lat': -3.63045, 'lon': 39.84992}}], 'overallOfficials': [{'name': 'James A Berkley, FRCPCH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KEMRI-Wellcome Trust Collaborative Research Program'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'KEMRI-Wellcome Trust Collaborative Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}