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Vascular & Endovascular Surgery »  Research »  Clinical Research »  Clinical Trials »  10-04615 (OMEGA-PAD I)

The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation

Official Title:

The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 2 Interventional 50 Years and older University of California, San Francisco 10-04615
NCT01310270
Enrolling patients

Study Design:


Principal Investigator

Associate Professor
Division of Vascular and Endovascular Surgery

Clinical Research Coordinator

San Francisco VA Medical Center
(415) 750-2115 Phone

Trial 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.

Eligibility

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

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 11/17/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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