The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
This trial is active, not recruiting.
|Treatment||crossover of r-alpha lipoic acid and placebo|
|Phase||phase 2/phase 3|
|Sponsor||Oregon State University|
|Collaborator||Oregon Health and Science University|
|Start date||August 2011|
|End date||July 2016|
|Trial size||50 participants|
|Trial identifier||NCT00764270, 5P01AT002034, AT002034-2|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: 12,20 & 32 weeks
time frame: 12, 20 & 32 weeks
Male or female participants from 50 years up to 70 years old.
Inclusion Criteria: - Documented congestive heart disease (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
|Official title||The Role of R-alpha Lipoic Acid in Treatment of Atherosclerotic Vascular Disease|
|Principal investigator||Balz Frei, PhD|
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