Antioxidant Functions of Lipoic Acid - Tabular View

Tracking Information

First Received Date ^ICMJE

July 29, 2003

Last Updated Date

September 28, 2007

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00065624 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Antioxidant Functions of Lipoic Acid

Official Title ^ICMJE

Antioxidant Functions of Lipoic Acid

Brief 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.

Detailed Description

As per Brief Summary

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Drug: lipoic acid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00065624

Responsible Party

Study ID Numbers ^ICMJE

R21 AT001062-01A2

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

James M May, MD

Vanderbilt University

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP