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

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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

Tracking Information
First Submitted Date  ICMJE October 16, 2009
First Posted Date  ICMJE October 19, 2009
Results First Submitted Date  ICMJE September 30, 2016
Results First Posted Date  ICMJE January 26, 2017
Last Update Posted Date January 26, 2017
Study Start Date  ICMJE August 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
  • Lipoic Acid Levels [ Time Frame: 1 hour ]
    Plasma concentration of LA
  • Lipoic Acid Levels [ Time Frame: 2 hours ]
    Plasma concentration of LA
  • Lipoic Acid Levels [ Time Frame: 3 hours ]
    Plasma concentration of LA
  • Lipoic Acid Levels [ Time Frame: 4 hours ]
    Plasma concentration of LA
  • Lipoic Acid Levels [ Time Frame: 24 hour ]
    Plasma concentration of LA
  • Lipoic Acid Levels [ Time Frame: 48 hour ]
    Plasma concentration of LA
  • cAMP Levels [ Time Frame: 2 hours ]
  • cAMP Levels [ Time Frame: 4 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
cAMP and lipoic acid levels [ Time Frame: 24 hour and 48 hour ]
Change History Complete list of historical versions of study NCT00997438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
  • RANTES Levels [ Time Frame: 24 hour ]
  • RANTES Levels [ Time Frame: 48 hour ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
cytokine and chemokine levels [ Time Frame: 24 hour and 48 hour ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Official Title  ICMJE Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Dietary Supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients
Study Arms  ICMJE
  • Experimental: MS - Secondary Progressive
    1200 mg of Lipoic acid supplement
    Intervention: Dietary Supplement: Lipoic Acid
  • Experimental: MS - Relapsing Remitting
    1200mg of Lipoic acid supplement
    Intervention: Dietary Supplement: Lipoic Acid
  • Experimental: Healthy Controls
    1200 mg of Lipoic acid supplement
    Intervention: Dietary Supplement: Lipoic Acid
Publications * Fiedler SE, Yadav V, Kerns AR, Tsang C, Markwardt S, Kim E, Spain R, Bourdette D, Salinthone S. Lipoic Acid Stimulates cAMP Production in Healthy Control and Secondary Progressive MS Subjects. Mol Neurobiol. 2018 Jul;55(7):6037-6049. doi: 10.1007/s12035-017-0813-y. Epub 2017 Nov 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2016)
69
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2009)
60
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00997438
Other Study ID Numbers  ICMJE 5659
OHSU eIRB#5659 ( Other Identifier: OHSU )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Carr, Portland VA Medical Center
Study Sponsor  ICMJE Portland VA Medical Center
Collaborators  ICMJE Oregon Health and Science University
Investigators  ICMJE
Principal Investigator: Daniel Carr, Ph.D Portland VA Medical Center and Oregon Health & Science University
PRS Account Portland VA Medical Center
Verification Date November 2016

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