The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention

Peripheral Arterial Disease Clinical Trial

— OMEGA-PVI  

Official title:

The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096757
• Other study ID #: 14-13123
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: March 2017

Study information

• Verified date: September 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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 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

Locations

Country	Name	City	State
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary patency	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).	6 months
Primary	Systemic Inflammatory bio-markers	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.	6 months
Secondary	Safety	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.	6 months

External Links

•   UCSF & SFVAMC Divisions of Vascular and Endovascular Surgery Clinical Trials