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NCT01310270 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— OMEGA-PAD  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01310270
Other study ID # 10-04615
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2011
Est. completion date December 2018

Study information
Verified date October 2021
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Pro-Omega
Pro-Omega, 4.4gm/day x 1 month
• Omega 3 Fatty Acid
4.4 gm/day for 1 month

Locations
Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endothelial Function Flow-mediated, brachial artery vasodilation (FMD) 1 month
Secondary Inflammatory bio-markers 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 1 month
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