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Vascular & Endovascular Surgery »  Research »  Clinical Research »  Clinical Trials »  13-11778 (OMEGA-PAD II)

The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II

Official Title:

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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 2 Interventional 50 Years and older University of California, San Francisco 13-11778
NCT01979874
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

Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve systemic inflammation, vascular function, and symptomatic status of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of inflammation.

Eligibility

Inclusion Criteria:

     1. Intermittent claudication (Rutherford 1-3)
     2. One of the following:
       Resting or exercise ankle-brachial index (ABI) <0.9
       toe pressure < 70 mm Hg
       documentation on imaging of greater than or equal to 50% stenosis in segments of
       aortoiliac arteries, femoral arteries, or tibial arteries
     3. Age 50 and more
Exclusion Criteria:

     1. Critical limb ischemia
     2. Hypersensitivity/allergies to fish or seafood
     3. Already on n-3 PUFA or equivalent
     4. Significant renal, hepatic, and inflammatory disease
     5. Concurrent severe infections
     6. Acute illness (myocardial infarction, stroke, major surgery within 30 days)
     7. Receiving immunosuppressive medications or steroids
     8. Age < 50

Detailed Description

The OMEGA-PAD II trial will be a 1:1 randomized, double-blinded trial comparing oral
supplementation of n-3 PUFA (4.4g/day) to placebo in claudicants (Rutherford stage 1-3) for 3
months. 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. Blood draws, vascular function testing and
6-minute walking tests will be performed at baseline and after 3 months. 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. 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.

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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