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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00764270
• Other study ID #: AT002034-2 (7187)
• Secondary ID: 5P01AT002034
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: August 2011
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Oregon State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Vascular Diseases

Intervention

Dietary Supplement:
• R-alpha lipoic acid
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 the other treatment placebo or 300 mg R-alpha-lipoic acid for 12 weeks

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon State University	National Center for Complementary and Integrative Health (NCCIH), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hs-CRP	High sensitive C-reactive protein	12,20 & 32 weeks
Secondary	8-lso-PGF2a	8-iso-prostaglandin F2alpha	12, 20 & 32 weeks