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

March 2, 2011
November 6, 2013
April 2011
November 2013   (final data collection date for primary outcome measure)
Endothelial Function [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Flow-mediated, brachial artery vasodilation (FMD)
Same as current
Complete list of historical versions of study NCT01310270 on ClinicalTrials.gov Archive Site
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
Inflammatory profile [ 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
Not Provided
Not Provided
 
The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Peripheral Arterial Disease
  • 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
  • Experimental: Pro-Omega
    High-dose, short-duration dietary omega-3 fatty acids supplementation
    Interventions:
    • Dietary Supplement: Pro-Omega
    • Dietary Supplement: Omega 3 Fatty Acid
  • Placebo Comparator: Placebo
    Interventions:
    • Dietary Supplement: Pro-Omega
    • Dietary Supplement: Omega 3 Fatty Acid
Grenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01310270
10-04615
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Marlene Grenon, MD University of California, San Francisco
University of California, San Francisco
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP