Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Portland VA Medical Center
- Enrollment
- 69
- Locations
- 4
- Primary Endpoint
- Lipoic Acid Levels
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Lipoic Acid Levels
Time Frame: 48 hour
Plasma concentration of LA
cAMP Levels
Time Frame: 4 hours
Secondary Outcomes
- RANTES Levels(48 hour)
Investigators
Daniel Carr
Research Career Scientist
Portland VA Medical Center