Journal
VASCULAR MEDICINE
Volume 18, Issue 5, Pages 263-274Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/1358863X13503695
Keywords
fatty acids; peripheral artery disease; randomized controlled trials
Categories
Funding
- University of California, San Francisco
- Northern California Institute for Research and Education
- Society for Vascular Surgery Seed Grant
- National Center for Research Resources [KL2RR024130]
- National Center for Advancing Translational Sciences
- National Institutes of Health, through UCSF-CTSI [KL2 TR000143]
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Despite current consensus guidelines recommending intensive cardiovascular risk factor management for peripheral artery disease (PAD), patients suffering from PAD continue to experience significant morbidity and mortality. This excess morbid burden is at least partially related to impaired vascular function and systemic inflammation. Interventions bridging this gap are critical. Dietary supplementation of n-3 polyunsaturated fatty acids (n-3 PUFA) has been shown to improve endothelial function and reduce inflammation in different cohorts, as well as to decrease cardiovascular events in secondary prevention trials in patients with coronary artery disease. Their effects in the PAD population are, however, less well understood. The OMEGA-PAD trial is a double-blinded, randomized, placebo-controlled trial that examines the impact of a high-dose, short-duration dietary oral supplementation of n-3 PUFA on vascular function and inflammation in patients with established PAD. The purpose of this article is to provide a detailed description of the design and methods of the OMEGA-PAD trial, and a summary of baseline characteristics of the cohort. ClinicalTrials.gov Identifier: NCT01310270
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