Trial Outcomes & Findings for Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis (NCT NCT00997438)
NCT ID: NCT00997438
Last Updated: 2017-01-26
Results Overview
Plasma concentration of LA
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
69 participants
Primary outcome timeframe
1 hour
Results posted on
2017-01-26
Participant Flow
Recruited at PVAMC and OHSU January 2012-December 2013 via fliers, word of mouth and MS clinic screening.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
24
|
24
|
|
Overall Study
COMPLETED
|
16
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
4
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Blood draw difficulty
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Exclusion criteria at visit 1
|
2
|
2
|
3
|
Baseline Characteristics
Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
MS - Secondary Progressive
n=16 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=21 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=20 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.5 years
n=99 Participants
|
51 years
n=107 Participants
|
49.5 years
n=206 Participants
|
54 years
n=7 Participants
|
|
Gender
Female
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Gender
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Plasma concentration of LA
Outcome measures
| Measure |
MS - Secondary Progressive
n=15 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=21 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=19 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
Lipoic Acid Levels
|
1376.14 ng/mL
Standard Error 359.41
|
1609.07 ng/mL
Standard Error 312.47
|
1428.05 ng/mL
Standard Error 330.02
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Plasma concentration of LA
Outcome measures
| Measure |
MS - Secondary Progressive
n=15 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=21 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=19 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
Lipoic Acid Levels
|
1125.71 ng/mL
Standard Error 291.40
|
1167.33 ng/mL
Standard Error 205.02
|
1348 ng/mL
Standard Error 205.91
|
PRIMARY outcome
Timeframe: 3 hoursPopulation: Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Plasma concentration of LA
Outcome measures
| Measure |
MS - Secondary Progressive
n=15 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=21 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=19 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
Lipoic Acid Levels
|
667.86 ng/mL
Standard Error 138.24
|
638.4 ng/mL
Standard Error 114.41
|
793.89 ng/mL
Standard Error 173.39
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Plasma concentration of LA
Outcome measures
| Measure |
MS - Secondary Progressive
n=15 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=21 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=19 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
Lipoic Acid Levels
|
268.6 ng/mL
Standard Error 73.15
|
252.75 ng/mL
Standard Error 33.85
|
394.1 ng/mL
Standard Error 129.15
|
PRIMARY outcome
Timeframe: 24 hourPopulation: Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Plasma concentration of LA
Outcome measures
| Measure |
MS - Secondary Progressive
n=15 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=21 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=19 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
Lipoic Acid Levels
|
0.78 ng/mL
Standard Error 0.13
|
0.87 ng/mL
Standard Error 0.05
|
0.78 ng/mL
Standard Error 0.06
|
PRIMARY outcome
Timeframe: 48 hourPopulation: Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).
Plasma concentration of LA
Outcome measures
| Measure |
MS - Secondary Progressive
n=15 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=21 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=19 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
Lipoic Acid Levels
|
0.55 ng/mL
Standard Error 0.15
|
0.7 ng/mL
Standard Error 0.05
|
0.57 ng/mL
Standard Error 0.04
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients
Outcome measures
| Measure |
MS - Secondary Progressive
n=16 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=19 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=19 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
cAMP Levels
|
75.9 pmol cAMP/mg protein
Interval 46.0 to 101.5
|
75.8 pmol cAMP/mg protein
Interval 56.8 to 113.0
|
96.6 pmol cAMP/mg protein
Interval 75.1 to 129.2
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients
Outcome measures
| Measure |
MS - Secondary Progressive
n=16 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=19 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=19 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
cAMP Levels
|
72.6 pmol cAMP/mg protein
Interval 56.8 to 90.1
|
79.1 pmol cAMP/mg protein
Interval 59.9 to 108.2
|
103.5 pmol cAMP/mg protein
Interval 63.0 to 149.6
|
SECONDARY outcome
Timeframe: 24 hourPopulation: Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.
Outcome measures
| Measure |
MS - Secondary Progressive
n=7 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=7 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=3 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
RANTES Levels
|
47184.9 pg/mL
Standard Error 15986.8
|
36281.4 pg/mL
Standard Error 13713.1
|
76751.7 pg/mL
Standard Error 44904.2
|
SECONDARY outcome
Timeframe: 48 hourPopulation: Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.
Outcome measures
| Measure |
MS - Secondary Progressive
n=7 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=7 Participants
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=3 Participants
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
RANTES Levels
|
44905.8 pg/mL
Standard Error 16659.6
|
42593.8 pg/mL
Standard Error 13848.9
|
60578.5 pg/mL
Standard Error 21878.8
|
Adverse Events
MS - Secondary Progressive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MS - Relapsing Remmitting
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MS - Secondary Progressive
n=21 participants at risk
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=24 participants at risk
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=24 participants at risk
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/21
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
MS - Secondary Progressive
n=21 participants at risk
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
MS - Relapsing Remmitting
n=24 participants at risk
1200mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
Healthy Controls
n=24 participants at risk
1200 mg of Lipoic acid supplement
Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients
|
|---|---|---|---|
|
Nervous system disorders
Exacerbation of pre-existing myelopathy
|
0.00%
0/21
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place