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Natural Antioxidants in the Treatment of Multiple Sclerosis
This study has been completed.
First Received: February 2, 2001   Last Updated: August 17, 2006   History of Changes
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00010842
  Purpose

The purpose of this study is to compare the effectiveness of three antioxidant regimens in treating the symptoms of multiple sclerosis (MS).


Condition Intervention Phase
Multiple Sclerosis
Drug: Ginkgo biloba
Drug: Alpha-lipoic acid
Drug: Vitamin E/Selenium
Drug: Essential fatty acids
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: Natural Antioxidants in the Treatment of Multiple Sclerosis

Resource links provided by NLM:


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

Study Start Date: September 1999
Estimated Study Completion Date: December 2004
Detailed Description:

Multiple sclerosis (MS) is an immune mediated disease of the central nervous system that affects over 350,000 Americans. T lymphocytes, macrophages and soluble mediators of inflammation cause demyelination and axonal injury in MS. Activated macrophages release nitric oxide and oxygen free radicals that cause demyelination and axonal injury in MS and experimental autoimmune encephalomyelitis (EAE). Natural antioxidants may favorably influence the course of MS by decreasing oxidative injury. Chronic relapsing EAE in mouse models is clinically and pathologically useful for testing potential therapies for MS.

This study will assess three natural antioxidant regimens for their potential as treatments for MS: Ginkgo biloba, alpha-lipoic acid/essential fatty acids, and vitamin E/selenium. The effects of each regimen will be compared to determine which regimen appears most effective at suppressing EAE and decreasing markers of oxidative injury in patients with MS. As part of this study, two smaller trials will be conducted. A Phase I/II trial in patients with MS will determine if the selected antioxidant regimen can decrease disease activity as detected with gadolinium-enhanced magnetic resonance imaging.

The results of this study will serve as the basis for a Phase III trial to assess the long term effectiveness of natural antioxidant therapy in MS.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria: - Pregnant - Other significant health problems

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010842

Locations
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97207
Sponsors and Collaborators
Investigators
Principal Investigator: Dr. Dennis Bourdette VA Medical Center-Brooklyn
  More Information

No publications provided

Study ID Numbers: P50 AT000066-01P1, P50 AT000066-01
Study First Received: February 2, 2001
Last Updated: August 17, 2006
ClinicalTrials.gov Identifier: NCT00010842     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Tocopherol acetate
Vitamin B Complex
Antioxidants
Autoimmune Diseases
Demyelinating Diseases
Alpha-lipoic Acid
Tocopherol
Trace Elements
Sclerosis
Ginkgo
Alpha-Tocopherol
Tocopherols
Selenium
Vitamin E
Multiple Sclerosis
Tocotrienol
Vitamins
Demyelinating Autoimmune Diseases, CNS
Tocotrienols
Micronutrients
Thioctic Acid
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Vitamin B Complex
Autoimmune Diseases
Antioxidants
Demyelinating Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Sclerosis
Protective Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Vitamins
Demyelinating Autoimmune Diseases, CNS
Micronutrients
Autoimmune Diseases of the Nervous System
Thioctic Acid

ClinicalTrials.gov processed this record on July 02, 2009