Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT03462056
Status:
COMPLETED
Last Update Posted:
2019-06-20
First Post:
2018-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-19', 'studyFirstSubmitDate': '2018-03-05', 'studyFirstSubmitQcDate': '2018-03-05', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI Z-score', 'timeFrame': '3 months', 'description': 'Change in BMI Z-score'}], 'secondaryOutcomes': [{'measure': 'Weight Z-score', 'timeFrame': '3 months', 'description': 'Change in Weight Z-score'}, {'measure': 'Body Composition', 'timeFrame': '3 months', 'description': 'Percent body fat mass and lean mass as measured by air displacement plethysmography'}, {'measure': 'Body Composition', 'timeFrame': '3 months', 'description': 'Percent body fat mass and lean mass as estimated by skinfold measurements (triceps and subscapular)'}, {'measure': 'Pulmonary Function', 'timeFrame': '3 months', 'description': 'Change in percent estimated forced expiratory volume at one second (FEV1), and forced vital capacity (FVC)'}, {'measure': 'Compliance of taking supplemental food', 'timeFrame': '3 months', 'description': 'Percent consumed as compared to amount recommended.'}, {'measure': 'Quality of Life', 'timeFrame': '3 months', 'description': 'Cystic Fibrosis Questionnaire-Revised (CFQ-R)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Children with cystic fibrosis require increased caloric intake to maintain appropriate growth, an important determinant of long-term outcomes. This study seeks to determine the feasibility of using a novel therapeutic food to promote weight gain and growth in children with cystic fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cystic Fibrosis diagnosed by sweat test or genetic testing.\n* Exocrine Pancreatic Insufficiency and receiving pancreatic enzyme replacement therapy\n* BMI or weight for age of less than the 50th percentile\n\nExclusion Criteria:\n\n* Cystic fibrosis related diabetes mellitus\n* Cystic fibrosis related liver disease.\n* Anaphylactic or other allergy to peanut, cow's milk, oat flour or other RUTF ingredients.\n* Patients who are status-post lung or liver transplantation\n* Currently receiving enteral supplemental nutrition through gastrostomy or nasogastric tube."}, 'identificationModule': {'nctId': 'NCT03462056', 'briefTitle': 'Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis', 'orgStudyIdInfo': {'id': '201712139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CF Ready to Use Supplemental Food.', 'description': 'Participants will receive Cystic Fibrosis Ready to Use Supplemental Food sufficient to provide approximately 20% of estimated daily caloric needs up to 500kcal of total calories, 18.5 grams of protein and 28g of fat. The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition', 'interventionNames': ['Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food']}], 'interventions': [{'name': 'Cystic Fibrosis Ready to Use Supplemental Food', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Specially formulated for use by children with Cystic Fibrosis', 'armGroupLabels': ['CF Ready to Use Supplemental Food.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Ryan T Pitman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Mark J Manary, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}