Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation (OMEGA-PAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01310270
Recruitment Status : Unknown
Verified January 2018 by Marlene Grenon, University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : March 8, 2011
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Marlene Grenon, University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Dietary Supplement: Pro-Omega Dietary Supplement: Omega 3 Fatty Acid Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
Actual Study Start Date : April 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Pro-Omega
High-dose, short-duration dietary omega-3 fatty acids supplementation
 Dietary Supplement: Pro-Omega
Pro-Omega, 4.4gm/day x 1 month

Dietary Supplement: Omega 3 Fatty Acid
4.4 gm/day for 1 month
Placebo Comparator: Placebo Dietary Supplement: Pro-Omega
Pro-Omega, 4.4gm/day x 1 month

Dietary Supplement: Omega 3 Fatty Acid
4.4 gm/day for 1 month


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Endothelial Function [ Time Frame: 1 month ]
    Flow-mediated, brachial artery vasodilation (FMD)


Secondary Outcome Measures :
  1. Inflammatory bio-markers [ Time Frame: 1 month ]
    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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310270


Contacts
Layout table for location contacts
Contact: Sukaynah Khetani, BS 415-353-4368 sukaynah.khetani@ucsf.edu
Contact: David Cheng, MD 415-221-4810 ext 4708 david.cheng4@va.gov

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Sukaynah Khetani    415-221-4810    sukaynah.khetani@ucsf.edu   
Principal Investigator: Marlene Grenon, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Marlene Grenon, MD University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Marlene Grenon, M.D, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01310270    
Other Study ID Numbers: 10-04615
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Inflammation
Pathologic Processes
Atherosclerosis
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases