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

November 30, 2016 updated by: Daniel Carr, Portland VA Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MS - Secondary Progressive
1200 mg of Lipoic acid supplement
Dietary supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients
Experimental: MS - Relapsing Remitting
1200mg of Lipoic acid supplement
Dietary supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients
Experimental: Healthy Controls
1200 mg of Lipoic acid supplement
Dietary supplement: Lipoic Acid
300 mg Lipoic acid tablets from Vital Nutrients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipoic Acid Levels
Time Frame: 1 hour
Plasma concentration of LA
1 hour
Lipoic Acid Levels
Time Frame: 2 hours
Plasma concentration of LA
2 hours
Lipoic Acid Levels
Time Frame: 3 hours
Plasma concentration of LA
3 hours
Lipoic Acid Levels
Time Frame: 4 hours
Plasma concentration of LA
4 hours
Lipoic Acid Levels
Time Frame: 24 hour
Plasma concentration of LA
24 hour
Lipoic Acid Levels
Time Frame: 48 hour
Plasma concentration of LA
48 hour
cAMP Levels
Time Frame: 2 hours
2 hours
cAMP Levels
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
RANTES Levels
Time Frame: 24 hour
24 hour
RANTES Levels
Time Frame: 48 hour
48 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portland VA Medical Center

Collaborators

Oregon Health and Science University

Investigators

  • Principal Investigator: Daniel Carr, Ph.D, Portland VA Medical Center and Oregon Health & Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5659
  • OHSU eIRB#5659 (Other Identifier: OHSU)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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