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

Peripheral Arterial Disease Clinical Trial

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

Clinical 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01979874
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 2
Start date February 2014
Completion date September 2017
View Details
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