Peripheral Arterial DiseaseOMEGA-PVINCT02096757
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
A study testing Pro-Omega in people with Peripheral Arterial Disease, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Pro-Omega
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
About this study
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).
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Pro-Omega, Pro-Omega Placebo
- Keywords
- Claudication, Critical Limb Ischemia, Endovascular procedure, Atherosclerosis
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Chronic Limb-Threatening Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-OmegaDietary supplement
Also called Fish Oil
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
Pro-Omega PlaceboOther
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Pro-Omega Placebo soybean capsules; 4.4gm/day (Nordic Naturals, Watsonville, CA, USA) 2 weeks prior to surgery and continued for 4 weeks after. Receives: Other: Pro-Omega Placebo |
| Pro-Omega | Experimental | 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. Receives: Dietary Supplement: Pro-Omega |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Safety
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren Gasper, M.D, Principal investigator, UCSF & SFVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096757
- Sponsor's protocol ID
- 14-13123
- Acronym
- OMEGA-PVI
- Status last verified
- Sep 2020
- First submitted
- 22 Mar 2014
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22363018Grenon 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.
PubMed 22572621Grenon 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.
PubMed 23830313Grenon 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.
PubMed 24052491
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
- ClinicalTrials.gov ID
- NCT02096757
- Acronym / sponsor ID
- OMEGA-PVI / 14-13123
- Conditions
- Peripheral Arterial Disease
- Keywords
- Claudication, Critical Limb Ischemia, Endovascular procedure, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Pro-Omega PlaceboPro-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 | Experimental | Dietary Supplement: Pro-OmegaHigh-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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro-OmegaAlso: Fish OilPro-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 | Dietary supplement | Pro-Omega |
| Pro-Omega PlaceboPlacebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Safety
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Background: PubMed 22363018Grenon 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.
- Background: PubMed 22572621Grenon 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.
- Background: PubMed 23830313Grenon 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.
- Background: PubMed 24052491Grenon 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.
- UCSF \& SFVAMC Divisions of Vascular and Endovascular Surgery Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Gasper, M.D principal investigator
UCSF & SFVAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro-Omega in people with Peripheral Arterial Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Inflammatory bio-markers (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02096757, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.