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

Oregon State University (OSU) logo

Oregon State University (OSU)

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Atherosclerosis

Treatments

Dietary Supplement: R-alpha lipoic acid

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00764270
5P01AT002034 (U.S. NIH Grant/Contract)
AT002034-2 (7187)

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups, including a placebo group

Lipoic acid treatment
Active Comparator group
Description:
Participants take lipoic acid with a washout period before or after placebo.
Treatment:
Dietary Supplement: R-alpha lipoic acid
Placebo treatment
Placebo Comparator group
Description:
Participants take placebo with a washout period before or after lipoic acid treatment
Treatment:
Dietary Supplement: R-alpha lipoic acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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