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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Dietary Supplement: Pro-Omega; Other: Pro-Omega Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02096757

14-13123

Details and patient eligibility

About

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).

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Pro-Omega Placebo soybean capsules; 4.4gm/day (Nordic Naturals, Watsonville, CA, USA) 2 weeks prior to surgery and continued for 4 weeks after.

Treatment:

Other: Pro-Omega Placebo

Pro-Omega

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Pro-Omega