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

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

Tracking Information

• First Submitted Date: November 1, 2013
• First Posted Date: November 8, 2013
• Last Update Posted Date: July 22, 2019
• Study Start Date: February 2014
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Peripheral Arterial Disease

Intervention

• 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

• 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 *

• Grenon SM, Hughes-Fulford M, Rapp J, Conte MS. Polyunsaturated fatty acids and peripheral artery disease. Vasc Med. 2012 Feb;17(1):51-63. doi: 10.1177/1358863X11429175. Review.
• Grenon SM, Aguado-Zuniga J, Hatton JP, Owens CD, Conte MS, Hughes-Fulford M. Effects of fatty acids on endothelial cells: inflammation and monocyte adhesion. J Surg Res. 2012 Sep;177(1):e35-43. doi: 10.1016/j.jss.2012.04.010. Epub 2012 Apr 27.
• Grenon SM, Conte MS, Nosova E, Alley H, Chong K, Harris WS, Vittinghoff E, Owens CD. Association between n-3 polyunsaturated fatty acid content of red blood cells and inflammatory biomarkers in patients with peripheral artery disease. J Vasc Surg. 2013 Nov;58(5):1283-90. doi: 10.1016/j.jvs.2013.05.024. Epub 2013 Jul 2.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 2, 2018): 26
• Original Estimated Enrollment (submitted: November 1, 2013): 70
• Actual Study Completion Date: September 2017
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 50 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01979874
• Other Study ID Numbers: 13-11778
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco
• Collaborators: Not Provided

Investigators

• Principal Investigator: Warren Gasper, MD; UCSF & SFVAMC

• PRS Account: University of California, San Francisco
• Verification Date: July 2019