Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-03-15 @ 11:13 PM
Study NCT ID:
NCT00308295
Status:
COMPLETED
Last Update Posted:
2007-10-16
First Post:
2006-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-05'}, 'lastUpdateSubmitDate': '2007-10-15', 'studyFirstSubmitDate': '2006-03-27', 'studyFirstSubmitQcDate': '2006-03-27', 'lastUpdatePostDateStruct': {'date': '2007-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether AHA-recommended fish oil therapy beneficially affects the pro-inflammatory/anti-inflammatory blood fatty acid balance'}], 'secondaryOutcomes': [{'measure': 'To test the safety and tolerability of fish oil therapy in hemodialysis patients'}, {'measure': 'To measure the effects of fish oil treatment on cardiovascular and inflammatory risk factors'}]}, 'conditionsModule': {'conditions': ['End-Stage Renal Disease Patients on Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The main goal of this study is to determine whether the American Heart Association-recommended fish oil dose is efficacious, safe, and tolerable in hemodialysis patients. The secondary objective is to test the effects of fish oil supplementation on inflammatory and cardiovascular markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exclusion Criteria:\n\n1. Age \\<18\n2. Pregnant individuals\n3. Fish oil or omega-3 supplementation in past 6 months\n4. Fish, corn, soybean, gelatin, or vanilla allergies\n5. Currently enrolled in a dietary or investigational drug study\n6. Life expectancy \\< 3 months\n7. Ongoing active illness requiring hospitalization\n8. Malabsorption syndromes\n9. Chronic heparin or coumadin anticoagulation (??)\n10. Active bleeding issues'}, 'identificationModule': {'nctId': 'NCT00308295', 'briefTitle': 'A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '0512-13'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fish oil capsules', 'type': 'DRUG'}, {'name': 'matched placebo capsules', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Nephrology Clinics', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'VeteransAdministration Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Allon Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}}}}