Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT00997438 |
Recruitment Status :
Completed
First Posted : October 19, 2009
Results First Posted : January 26, 2017
Last Update Posted : January 26, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | October 16, 2009 | |||
First Posted Date ICMJE | October 19, 2009 | |||
Results First Submitted Date ICMJE | September 30, 2016 | |||
Results First Posted Date ICMJE | January 26, 2017 | |||
Last Update Posted Date | January 26, 2017 | |||
Study Start Date ICMJE | August 2010 | |||
Actual Primary Completion Date | December 2013 (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 ] | |||
Change History | ||||
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 ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | 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. | |||
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:
The rest of the study involves
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). |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (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 Arms ICMJE |
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Publications * | Fiedler SE, Yadav V, Kerns AR, Tsang C, Markwardt S, Kim E, Spain R, Bourdette D, Salinthone S. Lipoic Acid Stimulates cAMP Production in Healthy Control and Secondary Progressive MS Subjects. Mol Neurobiol. 2018 Jul;55(7):6037-6049. doi: 10.1007/s12035-017-0813-y. Epub 2017 Nov 15. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
69 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date ICMJE | December 2013 | |||
Actual Primary Completion Date | December 2013 (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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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00997438 | |||
Other Study ID Numbers ICMJE | 5659 OHSU eIRB#5659 ( Other Identifier: OHSU ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Daniel Carr, Portland VA Medical Center | |||
Original Responsible Party | Daniel Carr, Oregon Health and Science University | |||
Current Study Sponsor ICMJE | Portland VA Medical Center | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Oregon Health and Science University | |||
Investigators ICMJE |
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PRS Account | Portland VA Medical Center | |||
Verification Date | November 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |