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The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II (OMEGA-PAD II)

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ClinicalTrials.gov Identifier: NCT01979874
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE November 1, 2013
First Posted Date  ICMJE November 8, 2013
Last Update Posted Date July 22, 2019
Study Start Date  ICMJE February 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
Systemic Inflammatory bio-markers [ Time Frame: 3 months ]
reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
Endothelial Function [ Time Frame: 3 months ]
Will increase brachial artery flow-mediated vasodilation (FMD)and peripheral resistance (AiX) and decrease arterial stiffness in the lower extremities (PWV).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2013)
Walking Performance [ Time Frame: 3 months ]
Will improve walking distance during 6-minute walk test and improve parameters on the walking impairment questionnaire (WIQ).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II
Official Title  ICMJE The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation II
Brief Summary Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve systemic inflammation, vascular function, and symptomatic status of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of inflammation.
Detailed Description The OMEGA-PAD II trial will be a 1:1 randomized, double-blinded trial comparing oral supplementation of n-3 PUFA (4.4g/day) to placebo in claudicants (Rutherford stage 1-3) for 3 months. Eligible patients will be screened according to specified inclusion and exclusion criteria. All patients will be treated per our current practice as reflected in the American Heart Association Practice guidelines on PAD. Blood draws, vascular function testing and 6-minute walking tests will be performed at baseline and after 3 months. n-3 PUFA supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals, Watsonville, California, USA), corresponding to a total of 4.4g/day. Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same color and shape as the treatment capsules.
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 (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day x 3 months
  • Other: ProOmega Placebo
    Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months
Study Arms  ICMJE
  • Experimental: Pro-Omega
    High-dose, short-duration dietary omega-3 fatty acids supplementation; 325mg of EPA and 225mg of DHA per capsule. 4.4gm/day x 3 months (Nordic Naturals, Watsonville, CA, USA)
    Intervention: Dietary Supplement: Pro-Omega
  • Placebo Comparator: Placebo
    Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months
    Intervention: Other: ProOmega Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2018)
26
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2013)
70
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Intermittent claudication (Rutherford 1-3)
  2. One of the following:

    1. Resting or exercise ankle-brachial index (ABI) <0.9
    2. toe pressure < 70 mm Hg
    3. documentation on imaging of greater than or equal to 50% stenosis in segments of aortoiliac arteries, femoral arteries, or tibial arteries
  3. Age 50 and more

Exclusion Criteria:

  1. Critical limb ischemia
  2. Hypersensitivity/allergies to fish or seafood
  3. Already on n-3 PUFA or equivalent
  4. Significant renal, hepatic, and inflammatory disease
  5. Concurrent severe infections
  6. Acute illness (myocardial infarction, stroke, major surgery within 30 days)
  7. Receiving immunosuppressive medications or steroids
  8. Age < 50
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 100 Years   (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 NCT01979874
Other Study ID Numbers  ICMJE 13-11778
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Warren Gasper, MD UCSF & SFVAMC
PRS Account University of California, San Francisco
Verification Date July 2019

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