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

• ClinicalTrials.gov Identifier: NCT00997438
• Recruitment Status: Completed
• First Posted: October 19, 2009
• Results First Posted: January 26, 2017
• Last Update Posted: January 26, 2017
• Sponsor: Portland VA Medical Center
• Collaborator: Oregon Health and Science University
• Information provided by (Responsible Party): Daniel Carr, Portland VA Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Dietary Supplement: Lipoic Acid	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 69 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
• Study Start Date: August 2010
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Lipoic Acid Levels [ Time Frame: 1 hour ]
   Plasma concentration of LA
2. Lipoic Acid Levels [ Time Frame: 2 hours ]
   Plasma concentration of LA
3. Lipoic Acid Levels [ Time Frame: 3 hours ]
   Plasma concentration of LA
4. Lipoic Acid Levels [ Time Frame: 4 hours ]
   Plasma concentration of LA
5. Lipoic Acid Levels [ Time Frame: 24 hour ]
   Plasma concentration of LA
6. Lipoic Acid Levels [ Time Frame: 48 hour ]
   Plasma concentration of LA
7. cAMP Levels [ Time Frame: 2 hours ]
8. cAMP Levels [ Time Frame: 4 hours ]

Secondary Outcome Measures :

1. RANTES Levels [ Time Frame: 24 hour ]
2. RANTES Levels [ Time Frame: 48 hour ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

Portland VA Medical Center

Portland, Oregon, United States, 97239

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Daniel Carr, Research Career Scientist, Portland VA Medical Center
• ClinicalTrials.gov Identifier: NCT00997438
• Other Study ID Numbers: 5659; OHSU eIRB#5659 ( Other Identifier: OHSU )
• First Posted: October 19, 2009
• Results First Posted: January 26, 2017
• Last Update Posted: January 26, 2017
• Last Verified: November 2016

Additional relevant MeSH terms:

Thioctic Acid; Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Vitamin B Complex; Vitamins; Micronutrients