Peripheral Arterial DiseaseOMEGA-PADNCT01310270
The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
A study testing Pro-Omega and Omega 3 Fatty Acid in people with Peripheral Arterial Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Pro-Omega and Omega 3 Fatty Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intermittent claudication
- resting or exercise Ankle-Brachial Index (ABI) <0.9
- age 50 and more
Who cannot join
- critical limb ischemia
- hypersensitivity/allergies to fish or seafood
- already on omega-3 fatty acids or equivalent
- significant renal, hepatic, and inflammatory disease
- concurrent severe infections
- acute illness (MI, stroke, major surgery within 30 days)
- receiving immunosuppressive medications or steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94115
About this study
The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by a panel of established circulating inflammatory biomarkers.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Pro-Omega, Omega 3 Fatty Acid
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-OmegaDietary supplement
Pro-Omega, 4.4gm/day x 1 month
Omega 3 Fatty AcidDietary supplement
4.4 gm/day for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Pro-Omega | Experimental | High-dose, short-duration dietary omega-3 fatty acids supplementation Receives: Dietary Supplement: Pro-Omega; Dietary Supplement: Omega 3 Fatty Acid |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Pro-Omega; Dietary Supplement: Omega 3 Fatty Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Flow-mediated, brachial artery vasodilation (FMD)
Measured: 1 month
Secondary outcomes (1)
Inflammatory bio-markers
Inflammatory bio-markers: C-reactive protein (hsCRP), interleukin-6 (IL-6), soluble intracellular adhesion molecule-1 (sICAM-1) and the anti-inflammatory mediator 15-epimeric lipoxin
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2018
- Study completionDec 2018
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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren Gasper, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310270
- Sponsor's protocol ID
- 10-04615
- Acronym
- OMEGA-PAD
- Status last verified
- Oct 2021
- First submitted
- 2 Mar 2011
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Grenon SM, Owens CD, Nosova EV, Hughes-Fulford M, Alley HF, Chong K, Perez S, Yen PK, Boscardin J, Hellmann J, Spite M, Conte MS. Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). J Am Heart Assoc. 2015 Aug 21;4(8):e002034. doi: 10.1161/JAHA.115.002034.
PubMed 26296857Chong KC, Owens CD, Park M, Alley HF, Boscardin WJ, Conte MS, Gasper WJ, Grenon SM. Relationship between kidney disease and endothelial function in peripheral artery disease. J Vasc Surg. 2014 Dec;60(6):1605-11. doi: 10.1016/j.jvs.2014.08.105. Epub 2014 Oct 16.
PubMed 25441679Alley H, Owens CD, Gasper WJ, Grenon SM. Ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery in clinical research. J Vis Exp. 2014 Oct 22;(92):e52070. doi: 10.3791/52070.
PubMed 25406739Grenon 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 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
- ClinicalTrials.gov ID
- NCT01310270
- Acronym / sponsor ID
- OMEGA-PAD / 10-04615
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 8 Mar 2011 (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.
The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by a panel of established circulating inflammatory biomarkers.
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 |
|---|---|---|
| Pro-Omega | Experimental | Dietary Supplement: Pro-Omega, Dietary Supplement: Omega 3 Fatty AcidHigh-dose, short-duration dietary omega-3 fatty acids supplementation |
| Placebo | Placebo comparator | Dietary Supplement: Pro-Omega, Dietary Supplement: Omega 3 Fatty Acid |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- intermittent claudication
- resting or exercise Ankle-Brachial Index (ABI) <0.9
- age 50 and more
Key exclusion criteria (7 listed)
- critical limb ischemia
- hypersensitivity/allergies to fish or seafood
- already on omega-3 fatty acids or equivalent
- significant renal, hepatic, and inflammatory disease
- concurrent severe infections
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-OmegaPro-Omega, 4.4gm/day x 1 month | Dietary supplement | Placebo, Pro-Omega |
| Omega 3 Fatty Acid4.4 gm/day for 1 month | Dietary supplement | Placebo, Pro-Omega |
Primary outcome
Endothelial Function
Time frame: 1 month
Flow-mediated, brachial artery vasodilation (FMD)
1 secondary outcome
Inflammatory bio-markers
Time frame: 1 month
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 5 Nov 2021.
- Derived from this study: PubMed 26296857Grenon SM, Owens CD, Nosova EV, Hughes-Fulford M, Alley HF, Chong K, Perez S, Yen PK, Boscardin J, Hellmann J, Spite M, Conte MS. Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). J Am Heart Assoc. 2015 Aug 21;4(8):e002034. doi: 10.1161/JAHA.115.002034.
- Derived from this study: PubMed 25441679Chong KC, Owens CD, Park M, Alley HF, Boscardin WJ, Conte MS, Gasper WJ, Grenon SM. Relationship between kidney disease and endothelial function in peripheral artery disease. J Vasc Surg. 2014 Dec;60(6):1605-11. doi: 10.1016/j.jvs.2014.08.105. Epub 2014 Oct 16.
- Derived from this study: PubMed 25406739Alley H, Owens CD, Gasper WJ, Grenon SM. Ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery in clinical research. J Vis Exp. 2014 Oct 22;(92):e52070. doi: 10.3791/52070.
- Derived from this study: 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.
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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, MD principal investigator
University of California, San Francisco
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 and Omega 3 Fatty Acid 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 3 inclusion and 7 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 5 Nov 2021. 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?
Endothelial Function (time frame: 1 month). 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 NCT01310270, 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 5 Nov 2021.