Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-04 @ 8:59 AM
Study NCT ID:
NCT02096757
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2014-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D007511', 'term': 'Ischemia'}]}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2014-03-22', 'studyFirstSubmitQcDate': '2014-03-22', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Primary patency', 'timeFrame': '6 months', 'description': 'We hypothesize that n-3 PUFA supplementation in the peri-PVI period will lead to an improvement in the primary patency of PVI at 6 months, as demonstrated by ultrasound (U/S).'}], 'primaryOutcomes': [{'measure': 'Systemic Inflammatory bio-markers', 'timeFrame': '6 months', 'description': 'Will reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '6 months', 'description': 'We hypothesize that n-3 PUFA supplementation in the peri-PVI period will be safe and will not lead to an increase in adverse events including bleeding and pseudoaneurysm formation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Claudication', 'Critical Limb Ischemia', 'Endovascular procedure', 'Atherosclerosis'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '22363018', 'type': 'BACKGROUND', 'citation': 'Grenon SM, Hughes-Fulford M, Rapp J, Conte MS. Polyunsaturated fatty acids and peripheral artery disease. Vasc Med. 2012 Feb;17(1):51-63. doi: 10.1177/1358863X11429175.'}, {'pmid': '22572621', 'type': 'BACKGROUND', 'citation': 'Grenon SM, Aguado-Zuniga J, Hatton JP, Owens CD, Conte MS, Hughes-Fulford M. Effects of fatty acids on endothelial cells: inflammation and monocyte adhesion. J Surg Res. 2012 Sep;177(1):e35-43. doi: 10.1016/j.jss.2012.04.010. Epub 2012 Apr 27.'}, {'pmid': '23830313', 'type': 'BACKGROUND', 'citation': 'Grenon SM, Conte MS, Nosova E, Alley H, Chong K, Harris WS, Vittinghoff E, Owens CD. Association between n-3 polyunsaturated fatty acid content of red blood cells and inflammatory biomarkers in patients with peripheral artery disease. J Vasc Surg. 2013 Nov;58(5):1283-90. doi: 10.1016/j.jvs.2013.05.024. Epub 2013 Jul 2.'}, {'pmid': '24052491', 'type': 'BACKGROUND', 'citation': 'Grenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19.'}], 'seeAlsoLinks': [{'url': 'http://vascular.surgery.ucsf.edu/research/clinical-research/clinical-trials.aspx', 'label': 'UCSF \\& SFVAMC Divisions of Vascular and Endovascular Surgery Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).', 'detailedDescription': 'The OMEGA-PVI trial is a double-blind, randomized (2:1 active:placebo), placebo-controlled trial with 30 patients aged ≥ 40 years with PAD. Eligible patients will be screened according to specified inclusion and exclusion criteria. All patients will be treated per our current practice as reflected in the American Heart Association Practice guidelines on PAD. n-3 PUFA supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals, Watsonville, California, USA), corresponding to a total of 4.4g/day given prior to and immediately after the operation. Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same color and shape as the treatment capsules. Blood draws, questionnaires, and ultrasounds will be done periodically. Specific measurements will include established markers of inflammation and resolution of inflammation, as well as ultrasound measures of PVI patency. The study proposed here has the potential to provide important new insights on the role of nutritional interventions in PAD, as well as to improve outcomes related to surgical revascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Disabling claudication or CLI as indication for PVI (Rutherford Class II-V)\n* Objective evidence of PAD e.g. ABI \\< 0.9, TBI \\< 0.6 or absent pedal pulses\n* Currently not taking high-dose n-3 PUFA, as defined by \\>2 g/day\n* Able to provide written informed consent AND\n* Undergoing a PVI (catheter-based therapy) involving the aorto-iliac segment, superficial femoral artery or popliteal artery.\n\nExclusion Criteria:\n\n* Age \\< 40 or \\> 90 years\n* Undergoing open surgical revascularization\n* Evidence of active infection in limb or foot or osteomyelitis\n* Extensive tissue loss (Rutherford Class VI Disease)\n* Diagnosed hypercoagulable state\n* Non-atherosclerotic/aneurysmal disease as indication for procedure\n* Chronic liver disease or myopathy\n* End-stage renal disease (CKD 5)\n* Poorly controlled diabetes (HbA1C \\> 8%)\n* Recent other major surgery or illness within 6 weeks\n* Use of immunosuppressives or chronic inflammatory disorders\n* History of organ transplantation\n* Pregnancy or plans to become pregnant\n* Condition in which patient life expectancy is less than one year'}, 'identificationModule': {'nctId': 'NCT02096757', 'acronym': 'OMEGA-PVI', 'briefTitle': 'The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention', 'orgStudyIdInfo': {'id': '14-13123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Pro-Omega Placebo soybean capsules; 4.4gm/day (Nordic Naturals, Watsonville, CA, USA) 2 weeks prior to surgery and continued for 4 weeks after.', 'interventionNames': ['Other: Pro-Omega Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Pro-Omega', 'description': 'High-dose, short-duration dietary omega-3 fatty acids supplementation; 325mg of EPA and 225mg of DHA per capsule. 4.4gm/day (Nordic Naturals, Watsonville, CA, USA) 2 weeks prior to surgery and continued for 4 weeks after.', 'interventionNames': ['Dietary Supplement: Pro-Omega']}], 'interventions': [{'name': 'Pro-Omega', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fish Oil'], 'description': 'Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after', 'armGroupLabels': ['Pro-Omega']}, {'name': 'Pro-Omega Placebo', 'type': 'OTHER', 'description': 'Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Veterans Affairs Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Warren Gasper, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF & SFVAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}