Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02647294
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polyunsaturated Fatty Acids in Patients With NAFLD.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, '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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-08', 'studyFirstSubmitDate': '2016-01-04', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with decreased liver fat content.', 'timeFrame': '12 months', 'description': 'Liver fat content in patients will be measured by magnetic resonance before and after the treatment. The number of patients with decreased liver fat content is expected to be higher in the treated group compare to placebo group.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with progression of liver fibrosis.', 'timeFrame': '12 months', 'description': 'Liver fibrosis will be measured by ultrasound (ARFI) before and after the treatment. The number of patients with no progression of fibrosis is expected to be higher in the treated group compare to placebo group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['NAFLD']}, 'referencesModule': {'references': [{'pmid': '35147302', 'type': 'RESULT', 'citation': 'Smid V, Dvorak K, Sedivy P, Kosek V, Lenicek M, Dezortova M, Hajslova J, Hajek M, Vitek L, Bechynska K, Bruha R. Effect of Omega-3 Polyunsaturated Fatty Acids on Lipid Metabolism in Patients With Metabolic Syndrome and NAFLD. Hepatol Commun. 2022 Jun;6(6):1336-1349. doi: 10.1002/hep4.1906. Epub 2022 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At the beginning and at the end of the study basic clinical and anthropometric data, as well as parameters of liver steatosis and fibrosis will be tested.', 'detailedDescription': 'Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At the beginning and at the end of the study basic clinical and anthropometric data will be recorded and the following parameters will be tested:\n\npanel of biochemistry and liver function tests: triglycerides, cholesterol, HDLcholesterol, LDL-cholesterol, glucose, insulin, serum bilirubin, liver tests, thyroid hormones, bile acids and their metabolites, albumin, total protein.\n\nBioactive metabolites, Inflammatory markers Non-invasive serum markers of liver fibrosis and steatohepatitis. Hyaluronic acid, NAFLD fibrosis score, cytokeratine-18 fragments. Ultrasonography with non-invasive measurement of fibrosis and steatosis, magnetic resonance spectroscopy for visceral and liver fat determination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with metabolic syndrome and NAFLD\n\nExclusion Criteria:\n\n* Age below 18 years\n* Gravidity\n* Incompliance.'}, 'identificationModule': {'nctId': 'NCT02647294', 'briefTitle': 'Polyunsaturated Fatty Acids in Patients With NAFLD.', 'organization': {'class': 'OTHER', 'fullName': 'General University Hospital, Prague'}, 'officialTitle': 'Nutrition-based Therapy of Liver Disease of Different Origin: Effect of n-3 Polyunsaturated Fatty Acid in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome.', 'orgStudyIdInfo': {'id': '15-28745A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polyunsaturated omega-3 fatty acids', 'description': 'Patients will receive n-3 fatty acids (Maxicor) 3,6 g/day.', 'interventionNames': ['Dietary Supplement: Maxicor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive placebo (soya oil)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Maxicor', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['n-3 polyunsaturated fatty acids', 'n-3 PUFA'], 'description': 'Patients with NAFLD will be randomly allocated to receive or n-3 PUFA (3,6 g/day, oral treatment) or placebo (1:1).', 'armGroupLabels': ['Polyunsaturated omega-3 fatty acids']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Patients with NAFLD will be randomly allocated to receive or placebo or n-3 PUFA for 12 months (1:1).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '128 08', 'city': 'Prague', 'state': 'Prague 2', 'country': 'Czechia', 'facility': 'General University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Radan Bruha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General University Hospital, Prague'}]}, 'ipdSharingStatementModule': {'url': 'https://int4.lf1.cuni.cz/en', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Will be available from 6/2023 by the end of 2025.', 'ipdSharing': 'YES', 'description': 'Available upon individual request.', 'accessCriteria': 'Available upon individual request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General University Hospital, Prague', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical associated professor', 'investigatorFullName': 'Radan Bruha', 'investigatorAffiliation': 'General University Hospital, Prague'}}}}