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

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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:

Collaborator:

Oregon Health and Science University

Information provided by (Responsible Party):

Daniel Carr, Portland VA Medical Center

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Multiple Sclerosis
Intervention:	Dietary Supplement: Lipoic Acid

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited at PVAMC and OHSU January 2012-December 2013 via fliers, word of mouth and MS clinic screening.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

Description

MS - Secondary Progressive

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

MS - Relapsing Remmitting

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Healthy Controls

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Participant Flow: Overall Study

	MS - Secondary Progressive	MS - Relapsing Remmitting	Healthy Controls
STARTED	21	24	24
COMPLETED	16	21	20
NOT COMPLETED	5	3	4
Blood draw difficulty	2	0	1
Withdrawal by Subject	1	1	0
Exclusion criteria at visit 1	2	2	3

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
MS - Secondary Progressive	1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
MS - Relapsing Remmitting	1200mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
Healthy Controls	1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
Total	Total of all reporting groups

Baseline Measures

	MS - Secondary Progressive	MS - Relapsing Remmitting	Healthy Controls	Total
Overall Participants Analyzed [Units: Participants]	16	21	20	57

Age [Units: Years] Median (Full Range)	57.5 (39 to 69)	51 (29 to 64)	49.5 (26 to 65)	54 (26 to 69)

Gender [Units: Participants] Count of Participants
Female	10 62.5%	14 66.7%	12 60.0%	36 63.2%
Male	6 37.5%	7 33.3%	8 40.0%	21 36.8%

Outcome Measures

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1. Primary:

Lipoic Acid Levels [ Time Frame: 1 hour ]

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Measure Type	Primary
Measure Title	Lipoic Acid Levels
Measure Description	Plasma concentration of LA
Time Frame	1 hour

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).

Reporting Groups

Description

MS - Secondary Progressive

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

MS - Relapsing Remmitting

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Healthy Controls

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Measured Values

	MS - Secondary Progressive	MS - Relapsing Remmitting	Healthy Controls
Participants Analyzed [Units: Participants]	15	21	19
Lipoic Acid Levels [Units: ng/mL] Mean (Standard Error)	1376.14 (359.41)	1609.07 (312.47)	1428.05 (330.02)

No statistical analysis provided for Lipoic Acid Levels

2. Primary:

Lipoic Acid Levels [ Time Frame: 2 hours ]

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Measure Type	Primary
Measure Title	Lipoic Acid Levels
Measure Description	Plasma concentration of LA
Time Frame	2 hours

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).

Reporting Groups

Description

MS - Secondary Progressive

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

MS - Relapsing Remmitting

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Healthy Controls

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Measured Values

	MS - Secondary Progressive	MS - Relapsing Remmitting	Healthy Controls
Participants Analyzed [Units: Participants]	15	21	19
Lipoic Acid Levels [Units: ng/mL] Mean (Standard Error)	1125.71 (291.40)	1167.33 (205.02)	1348 (205.91)

No statistical analysis provided for Lipoic Acid Levels

3. Primary:

Lipoic Acid Levels [ Time Frame: 3 hours ]

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Measure Type	Primary
Measure Title	Lipoic Acid Levels
Measure Description	Plasma concentration of LA
Time Frame	3 hours

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).

Reporting Groups

Description

MS - Secondary Progressive

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

MS - Relapsing Remmitting

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Healthy Controls

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Measured Values

	MS - Secondary Progressive	MS - Relapsing Remmitting	Healthy Controls
Participants Analyzed [Units: Participants]	15	21	19
Lipoic Acid Levels [Units: ng/mL] Mean (Standard Error)	667.86 (138.24)	638.4 (114.41)	793.89 (173.39)

No statistical analysis provided for Lipoic Acid Levels

4. Primary:

Lipoic Acid Levels [ Time Frame: 4 hours ]

Hide Outcome Measure 4

Measure Type	Primary
Measure Title	Lipoic Acid Levels
Measure Description	Plasma concentration of LA
Time Frame	4 hours

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).

Reporting Groups

Description

MS - Secondary Progressive

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

MS - Relapsing Remmitting

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Healthy Controls

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Measured Values

	MS - Secondary Progressive	MS - Relapsing Remmitting	Healthy Controls
Participants Analyzed [Units: Participants]	15	21	19
Lipoic Acid Levels [Units: ng/mL] Mean (Standard Error)	268.6 (73.15)	252.75 (33.85)	394.1 (129.15)

No statistical analysis provided for Lipoic Acid Levels

5. Primary:

Lipoic Acid Levels [ Time Frame: 24 hour ]

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6. Primary:

Lipoic Acid Levels [ Time Frame: 48 hour ]

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7. Primary:

cAMP Levels [ Time Frame: 2 hours ]

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8. Primary:

cAMP Levels [ Time Frame: 4 hours ]

Show Outcome Measure 8

9. Secondary:

RANTES Levels [ Time Frame: 24 hour ]

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10. Secondary:

RANTES Levels [ Time Frame: 48 hour ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Sonemany Salinthone
Organization: VA Portland Health Care System
phone: 5032208262 ext 54394
e-mail: salintho@ohsu.edu

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. 2017 Nov 15. doi: 10.1007/s12035-017-0813-y. [Epub ahead of print]

Responsible Party:	Daniel Carr, Portland VA Medical Center
ClinicalTrials.gov Identifier:	NCT00997438 History of Changes
Other Study ID Numbers:	5659 OHSU eIRB#5659 ( Other Identifier: OHSU )
First Submitted:	October 16, 2009
First Posted:	October 19, 2009
Results First Submitted:	September 30, 2016
Results First Posted:	January 26, 2017
Last Update Posted:	January 26, 2017

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