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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310270
First Posted: March 8, 2011
Last Update Posted: November 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Endothelial Function [ Time Frame: 1 month ]
    Flow-mediated, brachial artery vasodilation (FMD)


Secondary Outcome Measures:
  • Inflammatory bio-markers [ Time Frame: 1 month ]
    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
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
Dietary Supplement: Omega 3 Fatty Acid
4.4 gm/day for 1 month

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01310270     History of Changes
Other Study ID Numbers: 10-04615
First Submitted: March 2, 2011
First Posted: March 8, 2011
Last Update Posted: November 7, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Inflammation
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases