Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT02053857
Status:
COMPLETED
Last Update Posted:
2014-09-29
First Post:
2014-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007732', 'term': 'Kwashiorkor'}, {'id': 'D011502', 'term': 'Protein-Energy Malnutrition'}, {'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}], 'ancestors': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011488', 'term': 'Protein Deficiency'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-26', 'studyFirstSubmitDate': '2014-01-31', 'studyFirstSubmitQcDate': '2014-01-31', 'lastUpdatePostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DHA Level', 'timeFrame': '4 weeks', 'description': 'Blood plasma docosahexaenoic acid (DHA) levels'}, {'measure': 'EPA Level', 'timeFrame': '4 weeks', 'description': 'Blood plasma eicosapentaenoic acid (EPA) levels'}], 'secondaryOutcomes': [{'measure': 'Recovery Rate', 'timeFrame': '12 weeks', 'description': 'Proportion of children who recover from SAM'}, {'measure': 'Linear Growth', 'timeFrame': '12 weeks', 'description': 'Changes in length'}, {'measure': 'Ponderal Growth', 'timeFrame': '12 weeks', 'description': 'Changes in weight'}, {'measure': 'Growth', 'timeFrame': '12 weeks', 'description': 'Changes in mid-upper-arm circumference'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe acute malnutrition', 'polyunsaturated fatty acids', 'ready-to-use therapeutic food'], 'conditions': ['Kwashiorkor', 'Marasmus']}, 'descriptionModule': {'briefSummary': 'To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF.', 'detailedDescription': 'Since 2007, RUTF has been the recommended treatment for SAM. RUTF is not conducive to the growth of bacteria because of the low moisture content, does not require cooking, and has led to greater recovery rates than liquid milk formulations in direct comparisons. One expected benefit of the RUTF-P is improved outcomes due to the higher levels of essential fatty acids.\n\nThe essential fatty acid profile (i.e., the level of omega-3 and omega-6 fatty acids) of RUTF-P may have important implications for cognitive development of children, especially infants, with SAM who consume these foods as their sole dietary source for several weeks. In particular, an excess of omega-6 fatty acids (from sources such as peanut and corn oil) and a minimum of omega-3 fatty acids (from sources like flax) may fail to support optimal cognitive development and neural function.\n\nIn this prospective, double-blinded, randomized controlled clinical effectiveness trial, we will compare two RUTF products in the treatment of SAM to test the effects of the two different RUTF products on essential fatty acid status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* kwashiorkor and/or marasmus\n* 6-59 months of age\n* lives in local area near enrollment site\n\nExclusion Criteria:\n\n* recent (\\<4 months) therapeutic feeding for moderate or severe acute malnutrition\n* chronic medical condition (eg, Down syndrome, other congenital syndrome, chronic heart disease) that may make feeding and growth difficult (not to include HIV or TB)\n* caretaker refusal of 2 blood draws\n* ineligibility for outpatient therapy (ie, severe illness or anorexia requiring inpatient therapy)\n* caretaker expresses plans to move away from local area of clinic, making followup difficult'}, 'identificationModule': {'nctId': 'NCT02053857', 'briefTitle': 'Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Randomized, Double-blind Pilot Study of Polyunsaturated Fatty Acid-optimized Ready-to-use Therapeutic Food, Compared to Standard RUTF, in the Therapy of Severe Acute Malnutrition', 'orgStudyIdInfo': {'id': 'PUFA-RUTF Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RUTF', 'description': 'Standard RUTF at a dose of 175 kcal/kg/d', 'interventionNames': ['Dietary Supplement: RUTF', 'Drug: Amoxicillin']}, {'type': 'EXPERIMENTAL', 'label': 'RUTF-P', 'description': 'RUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d', 'interventionNames': ['Dietary Supplement: RUTF-P', 'Drug: Amoxicillin']}], 'interventions': [{'name': 'RUTF', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ready-to-use therapeutic food'], 'armGroupLabels': ['RUTF']}, {'name': 'RUTF-P', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['RUTF-P']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'armGroupLabels': ['RUTF', 'RUTF-P']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'University of Malawi College of Medicine', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'overallOfficials': [{'name': 'Mark J Manary, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Kenneth Maleta, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malawi'}, {'name': 'Chrissie Thakwalakwa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malawi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Malawi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}