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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

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).

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Dietary Supplement: Pro-Omega Other: Pro-Omega Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Actual Study Start Date : June 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

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 Name: Fish Oil




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096757


Locations
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United States, California
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Warren Gasper, M.D UCSF & SFVAMC
Additional Information:
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02096757    
Other Study ID Numbers: 14-13123
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Claudication
Critical Limb Ischemia
Endovascular procedure
Atherosclerosis
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Inflammation
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases