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

September 16, 2020 updated by: University of California, San Francisco
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Fish Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 22, 2014

First Submitted That Met QC Criteria

March 22, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-13123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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