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Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997438
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Daniel Carr, Portland VA Medical Center

Study Description
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Brief Summary:
The purpose of this study is to learn about how the antioxidant, lipoic acid, works in the body and how it may help in the management of relapsing remitting and secondary progressive multiple sclerosis. This study will compare how subject's and healthy volunteers bodies absorb and break down the supplement. This information may help in developing new therapies.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Dietary Supplement: Lipoic Acid Phase 1

Detailed Description:

Subjects (healthy control, relapsing remitting MS and secondary progressive MS) will be recruited through patients of investigators at Portland VA Medical Center (PVAMC), Oregon Health & Science University (OHSU), and the community using flyers and word of mouth.

The following will occur during screening:

  • Medical History Questionnaire to include questions about drug and alcohol use
  • Self Administered Expanded Disability Status Scale (EDSS) Questionnaire (MS participants only)
  • Vital Signs (heart rate, respiratory rate, blood pressure) will be measured and recorded
  • Physical Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)
  • Neurological Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)
  • Weight
  • Urine pregnancy test, if applicable
  • Anemia testing by finger stick (approximately 1 drop)

The rest of the study involves

  • Blood draws before lipoic acid is given, 1 hour, 2 hours, 3 hours, 4 hours, 24 and 48 hours after LA is given (3 ½ tablespoons)
  • Subjects will receive breakfast before they take LA
  • Subjects will take 4 - 300 mg capsules of lipoic acid (LA) for a total of 1200mg with about 1 cup of water

Blood will be processed to obtain plasma (from which lipoic acid concentrations will be measured) and PBMCs (from which cAMP and cytokines/chemokines will be measured).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Study Start Date : August 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MS - Secondary Progressive
1200 mg of Lipoic acid supplement
 Dietary Supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients
Experimental: MS - Relapsing Remitting
1200mg of Lipoic acid supplement
 Dietary Supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients
Experimental: Healthy Controls
1200 mg of Lipoic acid supplement
 Dietary Supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients


Outcome Measures
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Primary Outcome Measures :
  1. Lipoic Acid Levels [ Time Frame: 1 hour ]
    Plasma concentration of LA

  2. Lipoic Acid Levels [ Time Frame: 2 hours ]
    Plasma concentration of LA

  3. Lipoic Acid Levels [ Time Frame: 3 hours ]
    Plasma concentration of LA

  4. Lipoic Acid Levels [ Time Frame: 4 hours ]
    Plasma concentration of LA

  5. Lipoic Acid Levels [ Time Frame: 24 hour ]
    Plasma concentration of LA

  6. Lipoic Acid Levels [ Time Frame: 48 hour ]
    Plasma concentration of LA

  7. cAMP Levels [ Time Frame: 2 hours ]
  8. cAMP Levels [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. RANTES Levels [ Time Frame: 24 hour ]
  2. RANTES Levels [ Time Frame: 48 hour ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion/Exclusion criteria for MS subjects.

Inclusion criteria:

  1. Adult at least 18 years of age able to provide informed consent
  2. Currently diagnosed with relapsing remitting or secondary progressive MS

Exclusion criteria:

  1. Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
  2. History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
  3. History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
  4. MS exacerbation within 30 days of study entry
  5. Systemically administered corticosteroids within 30 days of study entry
  6. Pregnant or breast-feeding
  7. Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
  8. Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events
  9. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
  10. Anemia as indicated by a POC hemoglobin <12
  11. Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study

Inclusion/ Exclusion criteria for healthy controls.

Inclusion criteria:

1) Adult at least 18 years of age able to provide informed consent

Exclusion criteria:

  1. Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
  2. History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
  3. History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
  4. Pregnant or breast-feeding
  5. Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
  6. Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events
  7. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
  8. Anemia as indicated by a POC hemoglobin <12
  9. Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997438


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Portland VA Medical Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Portland VA Medical Center
Oregon Health and Science University
Investigators
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Principal Investigator: Daniel Carr, Ph.D Portland VA Medical Center and Oregon Health & Science University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniel Carr, Research Career Scientist, Portland VA Medical Center
ClinicalTrials.gov Identifier: NCT00997438    
Other Study ID Numbers: 5659
OHSU eIRB#5659 ( Other Identifier: OHSU )
First Posted: October 19, 2009    Key Record Dates
Results First Posted: January 26, 2017
Last Update Posted: January 26, 2017
Last Verified: November 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients