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NCT00065624 Clinical Trial

Antioxidant Functions of Lipoic Acid

Hypercholesterolemia Clinical Trial

Official title:
Antioxidant Functions of Lipoic Acid

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00065624
Other study ID # R21AT001062-01A2
Secondary ID
Status Completed
Phase Phase 2
First received July 29, 2003
Last updated September 28, 2007
Start date November 2003
Est. completion date July 2007

Study information
Verified date September 2007
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The goal of this study is to determine whether a short treatment with lipoic acid, an antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity and decreases oxidant stress in persons with elevated blood cholesterol.

Description:

As per Brief Summary

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 75 Years
Eligibility Inclusion criteria:

- Lipid criteria for inclusion are a plasma LDL between 160 and 190 mg/dl (total cholesterol usually 240-285 mg/dl)

- Less than 2 coronary risk factors, and already on a cholesterol-lowering diet.

Exclusion criteria:

- Overt or clinical atherosclerosis

- Diabetes

- Currently taking cholesterol-lowering medication.

- Subjects with other lipid disorders

- Subjects taking supplemental lipoic acid, vitamin C, or vitamin E.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• lipoic acid

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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