The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
OMEGA-PVI
1 other identifier
interventional
8
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedSeptember 18, 2020
September 1, 2020
2.8 years
March 22, 2014
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systemic Inflammatory bio-markers
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 Outcomes (1)
Safety
6 months
Other Outcomes (1)
Primary patency
6 months
Study Arms (2)
Placebo
PLACEBO COMPARATORPro-Omega Placebo soybean capsules; 4.4gm/day (Nordic Naturals, Watsonville, CA, USA) 2 weeks prior to surgery and continued for 4 weeks after.
Pro-Omega
EXPERIMENTALHigh-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.
Interventions
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
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121, United States
Related Publications (4)
Grenon SM, Hughes-Fulford M, Rapp J, Conte MS. Polyunsaturated fatty acids and peripheral artery disease. Vasc Med. 2012 Feb;17(1):51-63. doi: 10.1177/1358863X11429175.
PMID: 22363018BACKGROUNDGrenon SM, Aguado-Zuniga J, Hatton JP, Owens CD, Conte MS, Hughes-Fulford M. Effects of fatty acids on endothelial cells: inflammation and monocyte adhesion. J Surg Res. 2012 Sep;177(1):e35-43. doi: 10.1016/j.jss.2012.04.010. Epub 2012 Apr 27.
PMID: 22572621BACKGROUNDGrenon SM, Conte MS, Nosova E, Alley H, Chong K, Harris WS, Vittinghoff E, Owens CD. Association between n-3 polyunsaturated fatty acid content of red blood cells and inflammatory biomarkers in patients with peripheral artery disease. J Vasc Surg. 2013 Nov;58(5):1283-90. doi: 10.1016/j.jvs.2013.05.024. Epub 2013 Jul 2.
PMID: 23830313BACKGROUNDGrenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19.
PMID: 24052491BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Warren Gasper, M.D
UCSF & SFVAMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2014
First Posted
March 26, 2014
Study Start
June 1, 2014
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
September 18, 2020
Record last verified: 2020-09