Overview

This trial is active, not recruiting.

Condition atherosclerosis
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 November 2011
Trial size 50 participants
Trial identifier NCT00764270, 5P01AT002034, AT002034-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Participants take lipoic acid with a washout period before or after placebo.
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
(Placebo Comparator)
Participants take placebo with a washout period before or after lipoic acid treatment
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

Primary Outcomes

Measure
hs-CRP
time frame: 12,20 & 32 weeks

Secondary Outcomes

Measure
8-lso-PGF2a
time frame: 12, 20 & 32 weeks

Eligibility Criteria

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

Additional Information

Official title The Role of R-alpha Lipoic Acid in Treatment of Atherosclerotic Vascular Disease
Principal investigator Balz Frei, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Oregon State University.