The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation (OMEGA-PAD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01310270

First received: March 2, 2011

Last updated: November 6, 2013

Last verified: November 2013

History of Changes

Purpose

The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by a panel of established circulating inflammatory biomarkers.

Condition	Intervention	Phase
Peripheral Arterial Disease	Dietary Supplement: Pro-Omega Dietary Supplement: Omega 3 Fatty Acid	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation

Resource links provided by NLM:

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Endothelial Function [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Flow-mediated, brachial artery vasodilation (FMD)

Secondary Outcome Measures:

Inflammatory bio-markers [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Inflammatory bio-markers: C-reactive protein (hsCRP), interleukin-6 (IL-6), soluble intracellular adhesion molecule-1 (sICAM-1) and the anti-inflammatory mediator 15-epimeric lipoxin


Enrollment:	80
Study Start Date:	April 2011
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pro-Omega High-dose, short-duration dietary omega-3 fatty acids supplementation	Dietary Supplement: Pro-Omega Pro-Omega, 4.4gm/day x 1 month Other Name: Pro-Omega Dietary Supplement: Omega 3 Fatty Acid 4.4 gm/day for 1 month
Placebo Comparator: Placebo	Dietary Supplement: Pro-Omega Pro-Omega, 4.4gm/day x 1 month Other Name: Pro-Omega Dietary Supplement: Omega 3 Fatty Acid 4.4 gm/day for 1 month

Eligibility


Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

intermittent claudication
resting or exercise Ankle-Brachial Index (ABI) <0.9
age 50 and more

Exclusion Criteria:

critical limb ischemia
hypersensitivity/allergies to fish or seafood
already on omega-3 fatty acids or equivalent
significant renal, hepatic, and inflammatory disease
concurrent severe infections
acute illness (MI, stroke, major surgery within 30 days)
receiving immunosuppressive medications or steroids

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01310270

Locations


United States, California
University of California San Francisco
San Francisco, California, United States, 94115

Sponsors and Collaborators

University of California, San Francisco

Investigators


Principal Investigator:	Marlene Grenon, MD	University of California, San Francisco

More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chong KC, Owens CD, Park M, Alley HF, Boscardin WJ, Conte MS, Gasper WJ, Grenon SM. Relationship between kidney disease and endothelial function in peripheral artery disease. J Vasc Surg. 2014 Dec;60(6):1605-11. doi: 10.1016/j.jvs.2014.08.105. Epub 2014 Oct 16.

Alley H, Owens CD, Gasper WJ, Grenon SM. Ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery in clinical research. J Vis Exp. 2014 Oct 22;(92):e52070. doi: 10.3791/52070.

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.


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01310270 History of Changes
Other Study ID Numbers:	10-04615
Study First Received:	March 2, 2011
Last Updated:	November 6, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Peripheral Arterial Disease Peripheral Vascular Diseases Arterial Occlusive Diseases Arteriosclerosis	Atherosclerosis Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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