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

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

Tracking Information
First Submitted Date  ICMJE March 22, 2014
First Posted Date  ICMJE March 26, 2014
Last Update Posted Date September 18, 2020
Actual Study Start Date  ICMJE June 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 22, 2014)
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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Official Title  ICMJE The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Pro-Omega Placebo
  • 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.
    Intervention: Dietary Supplement: Pro-Omega
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2014)
30
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02096757
Other Study ID Numbers  ICMJE 14-13123
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Warren Gasper, M.D UCSF & SFVAMC
PRS Account University of California, San Francisco
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP