NCT01979874

Brief Summary

Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve systemic inflammation, vascular function, and symptomatic status of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2014

Typical duration for phase_2

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

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

3.6 years

First QC Date

November 1, 2013

Last Update Submit

July 18, 2019

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Systemic Inflammatory bio-markers

    reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.

    3 months

Secondary Outcomes (1)

  • Endothelial Function

    3 months

Other Outcomes (1)

  • Walking Performance

    3 months

Study Arms (2)

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 x 3 months (Nordic Naturals, Watsonville, CA, USA)

Dietary Supplement: Pro-Omega

Placebo

PLACEBO COMPARATOR

Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months

Other: ProOmega Placebo

Interventions

Pro-OmegaDIETARY_SUPPLEMENT

Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day x 3 months

Pro-Omega
ProOmega PlaceboOTHER

Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months

Placebo

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intermittent claudication (Rutherford 1-3)
  • One of the following:
  • Resting or exercise ankle-brachial index (ABI) \<0.9
  • toe pressure \< 70 mm Hg
  • documentation on imaging of greater than or equal to 50% stenosis in segments of aortoiliac arteries, femoral arteries, or tibial arteries
  • Age 50 and more

You may not qualify if:

  • Critical limb ischemia
  • Hypersensitivity/allergies to fish or seafood
  • Already on n-3 PUFA or equivalent
  • Significant renal, hepatic, and inflammatory disease
  • Concurrent severe infections
  • Acute illness (myocardial infarction, stroke, major surgery within 30 days)
  • Receiving immunosuppressive medications or steroids
  • Age \< 50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

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: 22363018BACKGROUND

  • Grenon 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: 22572621BACKGROUND

  • Grenon 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: 23830313BACKGROUND

  • 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: 24052491BACKGROUND

Related Links

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Warren Gasper, MD

    UCSF & SFVAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

November 1, 2013

First Posted

November 8, 2013

Study Start

February 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations

US(1)