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Clinical Trials/NCT01310270
NCT01310270
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country180 target enrollmentApril 2011
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ConditionsPeripheral Arterial Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
University of California, San Francisco
Enrollment
180
Locations
1
Primary Endpoint
Endothelial Function
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by a panel of established circulating inflammatory biomarkers.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
December 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •intermittent claudication
  • •resting or exercise Ankle-Brachial Index (ABI) \<0.9
  • •age 50 and more

Exclusion Criteria

  • •critical limb ischemia
  • •hypersensitivity/allergies to fish or seafood
  • •already on omega-3 fatty acids or equivalent
  • •significant renal, hepatic, and inflammatory disease
  • •concurrent severe infections
  • •acute illness (MI, stroke, major surgery within 30 days)
  • •receiving immunosuppressive medications or steroids

Outcomes

Primary Outcomes

Endothelial Function

Time Frame: 1 month

Flow-mediated, brachial artery vasodilation (FMD)

Secondary Outcomes

  • Inflammatory bio-markers(1 month)

Study Sites (1)

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