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

NCT01979874 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-07-22

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

DIETARY_SUPPLEMENT

Pro-Omega

Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day x 3 months

OTHER

ProOmega Placebo

Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months

Sponsors & Collaborators

Principal Investigators

  • Warren Gasper, MD · UCSF & SFVAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01979874 on ClinicalTrials.gov