The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
This study is currently recruiting participants.
Verified May 2013 by Oregon State University
Sponsor:
Oregon State University
Collaborators:
Oregon Health and Science University
Information provided by (Responsible Party):
Oregon State University
ClinicalTrials.gov Identifier:
NCT00764270
First received: October 1, 2008
Last updated: May 17, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atherosclerosis |
Dietary Supplement: Crossover of R-alpha lipoic acid and placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Role of R-alpha Lipoic Acid in Treatment of Atherosclerotic Vascular Disease |
Resource links provided by NLM:
Further study details as provided by Oregon State University:
Primary Outcome Measures:
- hs-CRP [ Time Frame: 12,20 & 32 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 8-lso-PGF2a [ Time Frame: 12, 20 & 32 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Lipoic acid crossover with placebo
All participants take lipoic acid and placebo in a crossover design with a washout period.
|
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
|
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764270
Contacts
| Contact: Jon Purnell, MD | 503-494-1056 | purnellj@ohsu.edu |
Locations
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97201 | |
| Principal Investigator: Jonathan Purnell, MD | |
Sponsors and Collaborators
Oregon State University
Oregon Health and Science University
Investigators
| Principal Investigator: | Balz Frei, PhD | Oregon State University |
More Information
No publications provided
| Responsible Party: | Oregon State University |
| ClinicalTrials.gov Identifier: | NCT00764270 History of Changes |
| Other Study ID Numbers: | AT002034-2, 5P01AT002034 |
| Study First Received: | October 1, 2008 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon State University:
|
atherosclerosis lipoic acid thioctic acid triglycerides |
overweight obesity oxidative stress inflammation |
Additional relevant MeSH terms:
|
Atherosclerosis Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Diseases Thioctic Acid Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 18, 2013