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| ID | Type | Description | Link |
|---|---|---|---|
| OHSU eIRB#5659 | Other Identifier | OHSU |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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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 (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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS - Secondary Progressive | Experimental | 1200 mg of Lipoic acid supplement |
|
| MS - Relapsing Remitting | Experimental | 1200mg of Lipoic acid supplement |
|
| Healthy Controls | Experimental | 1200 mg of Lipoic acid supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipoic Acid | Dietary Supplement | 300 mg Lipoic acid tablets from Vital Nutrients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lipoic Acid Levels | Plasma concentration of LA | 1 hour |
| Lipoic Acid Levels | Plasma concentration of LA | 2 hours |
| Lipoic Acid Levels | Plasma concentration of LA | 3 hours |
| Lipoic Acid Levels | Plasma concentration of LA | 4 hours |
| Lipoic Acid Levels | Plasma concentration of LA | 24 hour |
| Lipoic Acid Levels | Plasma concentration of LA | 48 hour |
| cAMP Levels | 2 hours | |
| cAMP Levels | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| RANTES Levels | 24 hour | |
| RANTES Levels | 48 hour |
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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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| Name | Affiliation | Role |
|---|---|---|
| Daniel Carr, Ph.D | Portland VA Medical Center and Oregon Health & Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States | ||
| Portland VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29143287 | Derived | 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. |
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Recruited at PVAMC and OHSU January 2012-December 2013 via fliers, word of mouth and MS clinic screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | MS - Secondary Progressive | 1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
| FG001 | MS - Relapsing Remmitting | 1200mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
| FG002 | Healthy Controls | 1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MS - Secondary Progressive | 1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
| BG001 | MS - Relapsing Remmitting | 1200mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lipoic Acid Levels | Plasma concentration of LA | Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s). | Posted | Mean | Standard Error | ng/mL | 1 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MS - Secondary Progressive | 1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | Non-systematic Assessment | Subject fainted and suffered facial abrasions as a result. CT scan and neuro consult determined likely vasovagal reaction causing syncope. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of pre-existing myelopathy | Nervous system disorders | Non-systematic Assessment | Subject indicated heat packs used prior to IV made have contributed to exacerbation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sonemany Salinthone | VA Portland Health Care System | 5032208262 | 54394 | salintho@ohsu.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Portland |
| Oregon |
| 97239 |
| United States |
| Exclusion criteria at visit 1 |
|
| BG002 | Healthy Controls | 1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Healthy Controls |
1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients |
|
|
| Primary | Lipoic Acid Levels | Plasma concentration of LA | Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s). | Posted | Mean | Standard Error | ng/mL | 2 hours |
|
|
|
| Primary | Lipoic Acid Levels | Plasma concentration of LA | Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s). | Posted | Mean | Standard Error | ng/mL | 3 hours |
|
|
|
| Primary | Lipoic Acid Levels | Plasma concentration of LA | Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s). | Posted | Mean | Standard Error | ng/mL | 4 hours |
|
|
|
| Primary | Lipoic Acid Levels | Plasma concentration of LA | Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s). | Posted | Mean | Standard Error | ng/mL | 24 hour |
|
|
|
| Primary | Lipoic Acid Levels | Plasma concentration of LA | Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s). | Posted | Mean | Standard Error | ng/mL | 48 hour |
|
|
|
| Primary | cAMP Levels | Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients | Posted | Median | Inter-Quartile Range | pmol cAMP/mg protein | 2 hours |
|
|
|
| Primary | cAMP Levels | Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients | Posted | Median | Inter-Quartile Range | pmol cAMP/mg protein | 4 hours |
|
|
|
| Secondary | RANTES Levels | Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place. | Posted | Mean | Standard Error | pg/mL | 24 hour |
|
|
|
| Secondary | RANTES Levels | Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place. | Posted | Mean | Standard Error | pg/mL | 48 hour |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | MS - Relapsing Remmitting | 1200mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients | 0 | 24 | 1 | 24 |
| EG002 | Healthy Controls | 1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients | 1 | 24 | 0 | 24 |
|
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |