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The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention — OMEGA-PVI  

Peripheral Arterial Disease Clinical Trial

Official title:
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention

Clinical Trial Summary

Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).

Clinical Trial Description

The OMEGA-PVI trial is a double-blind, randomized (2:1 active:placebo), placebo-controlled trial with 30 patients aged ≥ 40 years with PAD. 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. 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 given prior to and immediately after the operation. 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. Blood draws, questionnaires, and ultrasounds will be done periodically. Specific measurements will include established markers of inflammation and resolution of inflammation, as well as ultrasound measures of PVI patency. The study proposed here has the potential to provide important new insights on the role of nutritional interventions in PAD, as well as to improve outcomes related to surgical revascularization. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02096757
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase N/A
Start date June 2014
Completion date March 2017
View Details
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