NCT01310270

Brief 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 a panel of established circulating inflammatory biomarkers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

7.7 years

First QC Date

March 2, 2011

Last Update Submit

October 28, 2021

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function

    Flow-mediated, brachial artery vasodilation (FMD)

    1 month

Secondary Outcomes (1)

  • Inflammatory bio-markers

    1 month

Study Arms (2)

Pro-Omega

EXPERIMENTAL

High-dose, short-duration dietary omega-3 fatty acids supplementation

Dietary Supplement: Pro-OmegaDietary Supplement: Omega 3 Fatty Acid

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Pro-OmegaDietary Supplement: Omega 3 Fatty Acid

Interventions

Pro-OmegaDIETARY_SUPPLEMENT

Pro-Omega, 4.4gm/day x 1 month

PlaceboPro-Omega
Omega 3 Fatty AcidDIETARY_SUPPLEMENT

4.4 gm/day for 1 month

PlaceboPro-Omega

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intermittent claudication
  • resting or exercise Ankle-Brachial Index (ABI) \<0.9
  • age 50 and more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (4)

  • 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.

    PMID: 26296857DERIVED

  • Chong 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.

    PMID: 25441679DERIVED

  • Alley 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.

    PMID: 25406739DERIVED

  • Grenon 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: 24052491DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Warren Gasper, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

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 2, 2011

First Posted

March 8, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 5, 2021

Record last verified: 2021-10

Locations

US(1)