Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-03-03 @ 11:51 PM
Study NCT ID:
NCT01813006
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2013-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Omega-3 Fatty Acid on Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'C405603', 'term': 'Omacor'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'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'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-10', 'studyFirstSubmitDate': '2013-03-14', 'studyFirstSubmitQcDate': '2013-03-14', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lipid parameters', 'timeFrame': 'Baseline', 'description': 'Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions'}, {'measure': 'Lipid parameters', 'timeFrame': '3 months', 'description': 'Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions'}, {'measure': 'Lipid parameters', 'timeFrame': '6 months', 'description': 'Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions'}, {'measure': 'Lipid parameters', 'timeFrame': '9 months', 'description': 'Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions'}], 'primaryOutcomes': [{'measure': 'Reactive Hyperemia Index (RHI)', 'timeFrame': 'Baseline', 'description': 'Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry'}, {'measure': 'Reactive Hyperemia Index (RHI)', 'timeFrame': '3 months', 'description': 'Measure of endothelial function'}, {'measure': 'Reactive Hyperemia Index (RHI)', 'timeFrame': '6 months', 'description': 'Measure of endothelial function'}, {'measure': 'Reactive Hyperemia Index (RHI)', 'timeFrame': '9 months', 'description': 'Measure of endothelial function'}], 'secondaryOutcomes': [{'measure': 'Markers of inflammation', 'timeFrame': 'Baseline', 'description': 'Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors'}, {'measure': 'Inflammatory markers', 'timeFrame': '3 months', 'description': 'Serological markers of inflammation including cytokines, CRP and complement factors'}, {'measure': 'Inflammatory markers', 'timeFrame': '6 months', 'description': 'Serological markers of inflammation including cytokines, CRP and complement factors'}, {'measure': 'Inflammatory markers', 'timeFrame': '9 months', 'description': 'Serological markers of inflammation including cytokines, CRP and complement factors'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Familial Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '36999528', 'type': 'DERIVED', 'citation': 'Hande LN, Thunhaug H, Ludviksen J, Hovland A, Lappegard KT. No effect of omega-3 polyunsaturated fatty acid supplementation on inflammatory markers in familial hypercholesterolemia: a randomized crossover trial. Scand J Clin Lab Invest. 2023 May;83(3):152-159. doi: 10.1080/00365513.2023.2178499. Epub 2023 Mar 31.'}]}, 'descriptionModule': {'briefSummary': "Background\n\nFamilial hypercholesterolemia (FH) is an inherited disease in which the level of bad cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease, however its effect on patients with FH is not known.\n\nThe purpose of the study is to assess the effect of PUFA on patients with FH, with regard to inflammation measured in the blood and the effect on the blood vessels'ability to relax (endothelial function) by means of tonometry.\n\nHypothesis\n\nTreatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the endothelial function, and the treatment will also lead to a decrease in in several markers of inflammation and in lipids in the blood."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented familial hypercholesterolemia\n* age 18-60 years\n* on statin treatment for at least 12 months\n\nExclusion Criteria:\n\n* pregnancy or planned pregnancy\n* breast feeding\n* cancer\n* non-compliance\n* PUFA/omega-3 \\< 3 months before inclusion'}, 'identificationModule': {'nctId': 'NCT01813006', 'briefTitle': 'Effect of Omega-3 Fatty Acid on Endothelial Function', 'organization': {'class': 'OTHER', 'fullName': 'Nordlandssykehuset HF'}, 'officialTitle': 'Effect of Omega-3 Polyunsaturated Fat on Endothelial Function and Inflammatory Parameters in Familial Hypercholesterolemia - a Double Blind, Placebo-controlled Crossover Study', 'orgStudyIdInfo': {'id': '2011/899(REK)'}, 'secondaryIdInfos': [{'id': '2012-000505-68', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omega-3', 'description': 'Omega-3 fatty acids', 'interventionNames': ['Drug: Omega-3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo/olive oil', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Omega-3', 'type': 'DRUG', 'otherNames': ['Omacor'], 'armGroupLabels': ['Omega-3']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['olive oil'], 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8011', 'city': 'Bodø', 'country': 'Norway', 'facility': 'Division of Internal Medicine, Nordland Hospital', 'geoPoint': {'lat': 67.28267, 'lon': 14.37513}}], 'overallOfficials': [{'name': 'Knut T Lappegård, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nordland Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordlandssykehuset HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pronova BioPharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}