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The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease

This study is currently recruiting participants.
Verified October 2012 by Oregon State University
Sponsor:
Collaborators:
Oregon Health and Science University
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Oregon State University
ClinicalTrials.gov Identifier:
NCT00764270
First received: October 1, 2008
Last updated: October 18, 2012
Last verified: October 2012
History of Changes

October 1, 2008
October 18, 2012
August 2011
June 2013   (final data collection date for primary outcome measure)
hs-CRP [ Time Frame: 12,20 & 32 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764270 on ClinicalTrials.gov Archive Site
8-lso-PGF2a [ Time Frame: 12, 20 & 32 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
The Role of R-alpha Lipoic Acid in Treatment of Atherosclerotic Vascular Disease

The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors in people with documented heart disease and increased levels of inflammation.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atherosclerosis
Dietary Supplement: Crossover of R-alpha lipoic acid and placebo
300 mg R-alpha lipoic acid or placebo twice daily for 12 weeks, followed by a washout period of 12 weeks, followed by another treatment phase of placebo or 300 mg R-alpha-lipoic acid for 12 weeks
Lipoic acid crossover with placebo
All participants take lipoic acid and placebo in a crossover design with a washout period.
Intervention: Dietary Supplement: Crossover of R-alpha lipoic acid and placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented CHD (defined as at least one significant coronary stenosis > 50% on angiography, or history of documented myocardial infarction)
  • Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months)
  • Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy
  • On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P
  • No tobacco use within 3 months of the study
  • No laboratory evidence of renal, hepatic, or hematological abnormalities
  • Not currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;
  • Elevated levels of urinary and plasma F2-isoprostanes
  • Elevated plasma levels of hs-CRP
Both
50 Years to 70 Years
No
Contact: Sandy Bacon, RN 503-494-2003 bacons@ohsu.edu
United States
 
NCT00764270
AT002034-2, 5P01AT002034
Yes
Oregon State University
Oregon State University
  • Oregon Health and Science University
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Balz Frei, PhD Oregon State University
Oregon State University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP