ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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

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

1.  Primary:   Lipoic Acid Levels   [ Time Frame: 1 hour ]
  Hide Outcome Measure 1

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   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 ]
  Hide Outcome Measure 2

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   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 ]
  Hide Outcome Measure 3

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   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   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 ]

6.  Primary:   Lipoic Acid Levels   [ Time Frame: 48 hour ]

7.  Primary:   cAMP Levels   [ Time Frame: 2 hours ]

8.  Primary:   cAMP Levels   [ Time Frame: 4 hours ]

9.  Secondary:   RANTES Levels   [ Time Frame: 24 hour ]

10.  Secondary:   RANTES Levels   [ Time Frame: 48 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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):

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