Status:
COMPLETED
The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
Lead Sponsor:
Oregon State University
Collaborating Sponsors:
Oregon Health and Science University
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Atherosclerosis
Eligibility:
All Genders
50-70 years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00764270
Start Date
August 1 2011
End Date
October 1 2024
Last Update
April 11 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97201