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

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ClinicalTrials.gov Identifier: NCT01310270
Recruitment Status : Recruiting
First Posted : March 8, 2011
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Marlene Grenon, University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Arterial Disease Dietary Supplement: Pro-Omega Dietary Supplement: Omega 3 Fatty Acid Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
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
Actual Study Start Date : April 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. 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



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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

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


Contacts
Contact: Sukaynah Khetani, BS 415-353-4368 sukaynah.khetani@ucsf.edu
Contact: David Cheng, MD 415-221-4810 ext 4708 david.cheng4@va.gov

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Sukaynah Khetani    415-221-4810    sukaynah.khetani@ucsf.edu   
Principal Investigator: Marlene Grenon, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Marlene Grenon, MD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marlene Grenon, M.D, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01310270     History of Changes
Other Study ID Numbers: 10-04615
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

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