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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
Enrollment 69
Recruitment Details Recruited at PVAMC and OHSU January 2012-December 2013 via fliers, word of mouth and MS clinic screening.
Pre-assignment Details  
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Period Title: Overall Study
Started 21 24 24
Completed 16 21 20
Not Completed 5 3 4
Reason Not Completed
Blood draw difficulty             2             0             1
Withdrawal by Subject             1             1             0
Exclusion criteria at visit 1             2             2             3
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls Total
Hide Arm/Group Description

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Total of all reporting groups
Overall Number of Baseline Participants 16 21 20 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 21 participants 20 participants 57 participants
57.5
(39 to 69)
51
(29 to 64)
49.5
(26 to 65)
54
(26 to 69)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 21 participants 20 participants 57 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%
1.Primary Outcome
Title Lipoic Acid Levels
Hide Description Plasma concentration of LA
Time Frame 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 15 21 19
Mean (Standard Error)
Unit of Measure: ng/mL
1376.14  (359.41) 1609.07  (312.47) 1428.05  (330.02)
2.Primary Outcome
Title Lipoic Acid Levels
Hide Description Plasma concentration of LA
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 15 21 19
Mean (Standard Error)
Unit of Measure: ng/mL
1125.71  (291.40) 1167.33  (205.02) 1348  (205.91)
3.Primary Outcome
Title Lipoic Acid Levels
Hide Description Plasma concentration of LA
Time Frame 3 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 15 21 19
Mean (Standard Error)
Unit of Measure: ng/mL
667.86  (138.24) 638.4  (114.41) 793.89  (173.39)
4.Primary Outcome
Title Lipoic Acid Levels
Hide Description Plasma concentration of LA
Time Frame 4 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 15 21 19
Mean (Standard Error)
Unit of Measure: ng/mL
268.6  (73.15) 252.75  (33.85) 394.1  (129.15)
5.Primary Outcome
Title Lipoic Acid Levels
Hide Description Plasma concentration of LA
Time Frame 24 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 15 21 19
Mean (Standard Error)
Unit of Measure: ng/mL
0.78  (0.13) 0.87  (0.05) 0.78  (0.06)
6.Primary Outcome
Title Lipoic Acid Levels
Hide Description Plasma concentration of LA
Time Frame 48 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 15 21 19
Mean (Standard Error)
Unit of Measure: ng/mL
0.55  (0.15) 0.7  (0.05) 0.57  (0.04)
7.Primary Outcome
Title cAMP Levels
Hide Description [Not Specified]
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 16 19 19
Median (Inter-Quartile Range)
Unit of Measure: pmol cAMP/mg protein
75.9
(46 to 101.5)
75.8
(56.8 to 113)
96.6
(75.1 to 129.2)
8.Primary Outcome
Title cAMP Levels
Hide Description [Not Specified]
Time Frame 4 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 16 19 19
Median (Inter-Quartile Range)
Unit of Measure: pmol cAMP/mg protein
72.6
(56.8 to 90.1)
79.1
(59.9 to 108.2)
103.5
(63 to 149.6)
9.Secondary Outcome
Title RANTES Levels
Hide Description [Not Specified]
Time Frame 24 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 7 7 3
Mean (Standard Error)
Unit of Measure: pg/mL
47184.9  (15986.8) 36281.4  (13713.1) 76751.7  (44904.2)
10.Secondary Outcome
Title RANTES Levels
Hide Description [Not Specified]
Time Frame 48 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description:

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

Overall Number of Participants Analyzed 7 7 3
Mean (Standard Error)
Unit of Measure: pg/mL
44905.8  (16659.6) 42593.8  (13848.9) 60578.5  (21878.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Hide Arm/Group Description

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

1200 mg of Lipoic acid supplement

Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients

All-Cause Mortality
MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/24 (0.00%)      1/24 (4.17%)    
Nervous system disorders       
Syncope * [1]  0/21 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Subject fainted and suffered facial abrasions as a result. CT scan and neuro consult determined likely vasovagal reaction causing syncope.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MS - Secondary Progressive MS - Relapsing Remmitting Healthy Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      1/24 (4.17%)      0/24 (0.00%)    
Nervous system disorders       
Exacerbation of pre-existing myelopathy * [1]  0/21 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Subject indicated heat packs used prior to IV made have contributed to exacerbation
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
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