Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Lipoic Acid
Intervention description: 300 mg Lipoic acid tablets from Vital Nutrients
Intervention MeSH terms: Thioctic Acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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