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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Portland VA Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Daniel Carr, Portland VA Medical Center
ClinicalTrials.gov Identifier:
NCT00997438
First received: October 16, 2009
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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.

Subjects 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

Condition Intervention Phase
Multiple Sclerosis
Dietary Supplement: Lipoic Acid
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Portland VA Medical Center:

Primary Outcome Measures:
  • cAMP and lipoic acid levels [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
  • cAMP and lipoic acid levels [ Time Frame: 48 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cytokine and chemokine levels [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
  • cytokine and chemokine levels [ Time Frame: 48 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Remmitting
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997438

Contacts
Contact: Daniel Carr, Ph.D. 503-721-7918 carrd@ohsu.edu
Contact: Sonemany Salinthone, Ph.D. 095-56612 salintho@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Daniel Carr, Ph.D    503-721-7918    carrd@ohsu.edu   
Portland VA Medical Center Recruiting
Portland, Oregon, United States, 97239
Contact: Sonemany Salinthone, Ph.D       salintho@ohsu.edu   
Sponsors and Collaborators
Portland VA Medical Center
Oregon Health and Science University
Investigators
Principal Investigator: Daniel Carr, Ph.D Portland VA Medical Center and Oregon Health & Science University
  More Information

No publications provided

Responsible Party: Daniel Carr, Research Career Scientist, Portland VA Medical Center
ClinicalTrials.gov Identifier: NCT00997438     History of Changes
Other Study ID Numbers: 5659, OHSU eIRB#5659
Study First Received: October 16, 2009
Last Updated: January 24, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014