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Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lipoic Acid
Sponsored by
Portland VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion/Exclusion criteria for MS subjects.

Inclusion criteria:

  1. Adult at least 18 years of age able to provide informed consent
  2. Currently diagnosed with relapsing remitting or secondary progressive MS

Exclusion criteria:

  1. Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
  2. History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
  3. History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
  4. MS exacerbation within 30 days of study entry
  5. Systemically administered corticosteroids within 30 days of study entry
  6. Pregnant or breast-feeding
  7. Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
  8. Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events
  9. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
  10. Anemia as indicated by a POC hemoglobin <12
  11. Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study

Inclusion/ Exclusion criteria for healthy controls.

Inclusion criteria:

1) Adult at least 18 years of age able to provide informed consent

Exclusion criteria:

  1. Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days
  2. History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes
  3. History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia)
  4. Pregnant or breast-feeding
  5. Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study
  6. Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events
  7. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
  8. Anemia as indicated by a POC hemoglobin <12
  9. Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study

Sites / Locations

  • Oregon Health & Science University
  • Portland VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MS - Secondary Progressive

MS - Relapsing Remitting

Healthy Controls

Arm Description

1200 mg of Lipoic acid supplement

1200mg of Lipoic acid supplement

1200 mg of Lipoic acid supplement

Outcomes

Primary Outcome Measures

Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
Lipoic Acid Levels
Plasma concentration of LA
cAMP Levels
cAMP Levels

Secondary Outcome Measures

RANTES Levels
RANTES Levels

Full Information

First Posted
October 16, 2009
Last Updated
November 30, 2016
Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT00997438
Brief Title
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Official Title
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MS - Secondary Progressive
Arm Type
Experimental
Arm Description
1200 mg of Lipoic acid supplement
Arm Title
MS - Relapsing Remitting
Arm Type
Experimental
Arm Description
1200mg of Lipoic acid supplement
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
1200 mg of Lipoic acid supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Lipoic Acid
Intervention Description
300 mg Lipoic acid tablets from Vital Nutrients
Primary Outcome Measure Information:
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
1 hour
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
2 hours
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
3 hours
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
4 hours
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
24 hour
Title
Lipoic Acid Levels
Description
Plasma concentration of LA
Time Frame
48 hour
Title
cAMP Levels
Time Frame
2 hours
Title
cAMP Levels
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
RANTES Levels
Time Frame
24 hour
Title
RANTES Levels
Time Frame
48 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion/Exclusion criteria for MS subjects. Inclusion criteria: Adult at least 18 years of age able to provide informed consent Currently diagnosed with relapsing remitting or secondary progressive MS Exclusion criteria: Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia) MS exacerbation within 30 days of study entry Systemically administered corticosteroids within 30 days of study entry Pregnant or breast-feeding Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study Anemia as indicated by a POC hemoglobin <12 Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study Inclusion/ Exclusion criteria for healthy controls. Inclusion criteria: 1) Adult at least 18 years of age able to provide informed consent Exclusion criteria: Self-reported current substance/alcohol abuse/dependence or sobriety for less than 90 days History of traumatic brain injury as defined by a loss of consciousness of greater than 30 minutes History of a medical condition associated with persisting cognitive problems or serious central nervous system dysfunction (e.g., brain tumor,dementia) Pregnant or breast-feeding Anti-coagulant use such as Heparin, Coumadin, or Aspirin while enrolled in the study Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase the risk of subject experiencing adverse events Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study Anemia as indicated by a POC hemoglobin <12 Subjects of child bearing potential or subjects capable of causing pregnancy who are sexually active and unwilling to use effective contraceptive methods for the duration of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Carr, Ph.D
Organizational Affiliation
Portland VA Medical Center and Oregon Health & Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29143287
Citation
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.
Results Reference
derived

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Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

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