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

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ClinicalTrials.gov Identifier: NCT01310270
Recruitment Status : Unknown
Verified January 2018 by Marlene Grenon, University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : March 8, 2011
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Marlene Grenon, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE March 2, 2011
First Posted Date  ICMJE March 8, 2011
Last Update Posted Date January 4, 2018
Actual Study Start Date  ICMJE April 2011
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2011)
Endothelial Function [ Time Frame: 1 month ]
Flow-mediated, brachial artery vasodilation (FMD)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2011)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2011)
Inflammatory profile [ 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
Official Title  ICMJE The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 2, 2018)
180
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2011)
80
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01310270
Other Study ID Numbers  ICMJE 10-04615
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marlene Grenon, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marlene Grenon, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date January 2018

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