Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 16, 2009 | ||||||||
| Last Updated Date | January 24, 2012 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
cAMP and lipoic acid levels [ Time Frame: 24 hour and 48 hour ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00997438 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
cytokine and chemokine levels [ Time Frame: 24 hour and 48 hour ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | 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. 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:
The rest of the study involves
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Multiple Sclerosis | ||||||||
| Intervention ICMJE | Dietary Supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion/Exclusion criteria for MS subjects. Inclusion criteria:
Exclusion criteria:
Inclusion/ Exclusion criteria for healthy controls. Inclusion criteria: 1) Adult at least 18 years of age able to provide informed consent Exclusion criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00997438 | ||||||||
| Other Study ID Numbers ICMJE | 5659, OHSU eIRB#5659 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Daniel Carr, Portland VA Medical Center | ||||||||
| Study Sponsor ICMJE | Portland VA Medical Center | ||||||||
| Collaborators ICMJE | Oregon Health and Science University | ||||||||
| Investigators ICMJE |
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| Information Provided By | Portland VA Medical Center | ||||||||
| Verification Date | January 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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