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Antioxidant Functions of Lipoic Acid

This study has been completed.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00065624
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Drug: lipoic acid
Phase II

Genetics Home Reference related topics:   hypercholesterolemia   

MedlinePlus related topics:   Antioxidants    Cholesterol   

Drug Information available for:   Thioctic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Antioxidant Functions of Lipoic Acid

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:   16
Study Start Date:   November 2003
Study Completion Date:   July 2007

Detailed Description:

As per Brief Summary

  Eligibility
Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065624

Locations
United States, Tennessee
Vanderbilt University Medical Center    
      Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Investigators
Principal Investigator:     James M May, MD     Vanderbilt University    
  More Information


Study ID Numbers:   R21 AT001062-01A2
First Received:   July 29, 2003
Last Updated:   September 28, 2007
ClinicalTrials.gov Identifier:   NCT00065624
Health Authority:   United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Lipoic acid  
F2-isoprostanes  
endothelial dysfunction  
natural product  

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Metabolic disorder
Hypercholesterolemia
Thioctic Acid
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antioxidants
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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