The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention (OMEGA-PVI)

• ClinicalTrials.gov Identifier: NCT02096757
• Recruitment Status: Completed
• First Posted: March 26, 2014
• Last Update Posted: September 18, 2020
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

Brief Summary:

Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Dietary Supplement: Pro-Omega; Other: Pro-Omega Placebo	Not Applicable

Detailed Description:

The OMEGA-PVI trial is a double-blind, randomized (2:1 active:placebo), placebo-controlled trial with 30 patients aged ≥ 40 years with PAD. 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. 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 given prior to and immediately after the operation. 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. Blood draws, questionnaires, and ultrasounds will be done periodically. Specific measurements will include established markers of inflammation and resolution of inflammation, as well as ultrasound measures of PVI patency. The study proposed here has the potential to provide important new insights on the role of nutritional interventions in PAD, as well as to improve outcomes related to surgical revascularization.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
• Actual Study Start Date: June 2014
• Actual Primary Completion Date: March 2017
• Actual Study Completion Date: March 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Pro-Omega Placebo soybean capsules; 4.4gm/day (Nordic Naturals, Watsonville, CA, USA) 2 weeks prior to surgery and continued for 4 weeks after.	Other: Pro-Omega Placebo; Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after
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 (Nordic Naturals, Watsonville, CA, USA) 2 weeks prior to surgery and continued for 4 weeks after.	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 2 weeks prior to surgery and continued for 4 weeks after; Other Name: Fish Oil

Outcome Measures

Primary Outcome Measures :

1. Systemic Inflammatory bio-markers [ Time Frame: 6 months ]
   Will reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.

Secondary Outcome Measures :

1. Safety [ Time Frame: 6 months ]
   We hypothesize that n-3 PUFA supplementation in the peri-PVI period will be safe and will not lead to an increase in adverse events including bleeding and pseudoaneurysm formation.

Other Outcome Measures:

1. Primary patency [ Time Frame: 6 months ]
   We hypothesize that n-3 PUFA supplementation in the peri-PVI period will lead to an improvement in the primary patency of PVI at 6 months, as demonstrated by ultrasound (U/S).

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Disabling claudication or CLI as indication for PVI (Rutherford Class II-V)
• Objective evidence of PAD e.g. ABI < 0.9, TBI < 0.6 or absent pedal pulses
• Currently not taking high-dose n-3 PUFA, as defined by >2 g/day
• Able to provide written informed consent AND
• Undergoing a PVI (catheter-based therapy) involving the aorto-iliac segment, superficial femoral artery or popliteal artery.

Exclusion Criteria:

• Age < 40 or > 90 years
• Undergoing open surgical revascularization
• Evidence of active infection in limb or foot or osteomyelitis
• Extensive tissue loss (Rutherford Class VI Disease)
• Diagnosed hypercoagulable state
• Non-atherosclerotic/aneurysmal disease as indication for procedure
• Chronic liver disease or myopathy
• End-stage renal disease (CKD 5)
• Poorly controlled diabetes (HbA1C > 8%)
• Recent other major surgery or illness within 6 weeks
• Use of immunosuppressives or chronic inflammatory disorders
• History of organ transplantation
• Pregnancy or plans to become pregnant
• Condition in which patient life expectancy is less than one year

Contacts and Locations

Locations

United States, California

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States, 94121

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Warren Gasper, M.D; UCSF & SFVAMC

More Information

Additional Information:

UCSF & SFVAMC Divisions of Vascular and Endovascular Surgery Clinical Trials 

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.

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02096757
• Other Study ID Numbers: 14-13123
• First Posted: March 26, 2014
• Last Update Posted: September 18, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:

Claudication; Critical Limb Ischemia; Endovascular procedure; Atherosclerosis

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Inflammation; Pathologic Processes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases