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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01310270
First received: March 2, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Peripheral Arterial Disease
Dietary Supplement: Pro-Omega
Dietary Supplement: Omega 3 Fatty Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Endothelial Function [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Flow-mediated, brachial artery vasodilation (FMD)


Secondary Outcome Measures:
  • Inflammatory bio-markers [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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


Enrollment: 80
Study Start Date: April 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Pro-Omega
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
Other Name: Pro-Omega
Dietary Supplement: Omega 3 Fatty Acid
4.4 gm/day for 1 month

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01310270

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Marlene Grenon, MD University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01310270     History of Changes
Other Study ID Numbers: 10-04615
Study First Received: March 2, 2011
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014