Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Dietary Supplement: Lipoic Acid
- Registration Number
- NCT00997438
- Lead Sponsor
- Portland VA Medical Center
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MS - Secondary Progressive Lipoic Acid 1200 mg of Lipoic acid supplement MS - Relapsing Remitting Lipoic Acid 1200mg of Lipoic acid supplement Healthy Controls Lipoic Acid 1200 mg of Lipoic acid supplement
- Primary Outcome Measures
Name Time Method Lipoic Acid Levels 48 hour Plasma concentration of LA
cAMP Levels 4 hours
- Secondary Outcome Measures
Name Time Method RANTES Levels 48 hour
Trial Locations
- Locations (2)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Portland VA Medical Center
🇺🇸Portland, Oregon, United States