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The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation (OMEGA-PAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01310270
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Dietary Supplement: Pro-Omega Dietary Supplement: Omega 3 Fatty Acid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
Actual Study Start Date : April 2011
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pro-Omega
High-dose, short-duration dietary omega-3 fatty acids supplementation
 Dietary Supplement: Pro-Omega
Pro-Omega, 4.4gm/day x 1 month

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

Dietary Supplement: Omega 3 Fatty Acid
4.4 gm/day for 1 month


Outcome Measures
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Primary Outcome Measures :
  1. Endothelial Function [ Time Frame: 1 month ]
    Flow-mediated, brachial artery vasodilation (FMD)


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310270


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Warren Gasper, MD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01310270    
Other Study ID Numbers: 10-04615
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Inflammation
Pathologic Processes
Atherosclerosis
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases