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OpenTrials
Completed

NCT Number: NCT01310270

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pro-Omega

Dietary Supplement

Pro-Omega, 4.4gm/day x 1 month

Omega 3 Fatty Acid

Dietary Supplement

4.4 gm/day for 1 month

Primary outcomes

  1. Endothelial Function

    Time frame: 1 month

    Flow-mediated, brachial artery vasodilation (FMD)

Secondary outcomes

  1. Inflammatory bio-markers

    Time frame: 1 month

    Inflammatory bio-markers: C-reactive protein (hsCRP), interleukin-6 (IL-6), soluble intracellular adhesion molecule-1 (sICAM-1) and the anti-inflammatory mediator 15-epimeric lipoxin

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: OMEGA-PAD

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2011
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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