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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Pro-Omega Placebo

Intervention Type OTHER

Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after

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.

Group Type EXPERIMENTAL

Pro-Omega

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Other Intervention Names

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Fish Oil

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No