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

Sponsor:	Portland VA Medical Center
Collaborator:	Oregon Health and Science University
Information provided by (Responsible Party):	Daniel Carr, Portland VA Medical Center
ClinicalTrials.gov Identifier:	NCT00997438

Purpose

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 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

Condition	Intervention	Phase
Multiple Sclerosis	Dietary Supplement: Lipoic Acid	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Multiple Sclerosis

Drug Information available for: Thioctic Acid

U.S. FDA Resources

Further study details as provided by Portland VA Medical Center:

Primary Outcome Measures:

cAMP and lipoic acid levels [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
cAMP and lipoic acid levels [ Time Frame: 48 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cytokine and chemokine levels [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
cytokine and chemokine levels [ Time Frame: 48 hour ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Remmitting 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997438

Contacts

Contact: Daniel Carr, Ph.D.	503-721-7918	carrd@ohsu.edu
Contact: Sonemany Salinthone, Ph.D.	095-56612	salintho@ohsu.edu

Locations

United States, Oregon
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Daniel Carr, Ph.D 503-721-7918 carrd@ohsu.edu
Portland VA Medical Center	Recruiting
Portland, Oregon, United States, 97239
Contact: Sonemany Salinthone, Ph.D salintho@ohsu.edu

Sponsors and Collaborators

Portland VA Medical Center

Oregon Health and Science University

Investigators

Principal Investigator:

Daniel Carr, Ph.D

Portland VA Medical Center and Oregon Health & Science University

More Information

No publications provided

Responsible Party:	Daniel Carr, Research Career Scientist, Portland VA Medical Center
ClinicalTrials.gov Identifier:	NCT00997438 History of Changes
Other Study ID Numbers:	5659, OHSU eIRB#5659
Study First Received:	October 16, 2009
Last Updated:	January 24, 2012
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Anti-Inflammatory Agents
Thioctic Acid

Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012