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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Sponsor:
Portland VA Medical Center
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Daniel Carr, Portland VA Medical Center
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Multiple Sclerosis |
Intervention |
Dietary Supplement: Lipoic Acid |
Enrollment | 69 |
Participant Flow
Recruitment Details | Recruited at PVAMC and OHSU January 2012-December 2013 via fliers, word of mouth and MS clinic screening. |
Pre-assignment Details |
Arm/Group Title | MS - Secondary Progressive | MS - Relapsing Remmitting | Healthy Controls |
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1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
1200mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
Period Title: Overall Study | |||
Started | 21 | 24 | 24 |
Completed | 16 | 21 | 20 |
Not Completed | 5 | 3 | 4 |
Reason Not Completed | |||
Blood draw difficulty | 2 | 0 | 1 |
Withdrawal by Subject | 1 | 1 | 0 |
Exclusion criteria at visit 1 | 2 | 2 | 3 |
Baseline Characteristics
Arm/Group Title | MS - Secondary Progressive | MS - Relapsing Remmitting | Healthy Controls | Total | |
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1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
1200mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
Total of all reporting groups | |
Overall Number of Baseline Participants | 16 | 21 | 20 | 57 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 16 participants | 21 participants | 20 participants | 57 participants | |
57.5
(39 to 69)
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51
(29 to 64)
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49.5
(26 to 65)
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54
(26 to 69)
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Gender
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 16 participants | 21 participants | 20 participants | 57 participants | |
Female |
10 62.5%
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14 66.7%
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12 60.0%
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36 63.2%
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Male |
6 37.5%
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7 33.3%
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8 40.0%
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21 36.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Sonemany Salinthone |
Organization: | VA Portland Health Care System |
Phone: | 5032208262 ext 54394 |
EMail: | salintho@ohsu.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Daniel Carr, Portland VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00997438 |
Other Study ID Numbers: |
5659 OHSU eIRB#5659 ( Other Identifier: OHSU ) |
First Submitted: | October 16, 2009 |
First Posted: | October 19, 2009 |
Results First Submitted: | September 30, 2016 |
Results First Posted: | January 26, 2017 |
Last Update Posted: | January 26, 2017 |