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

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

Participant Flow

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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
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

Baseline Characteristics

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Arm/Group Title		MS - Secondary Progressive	MS - Relapsing Remmitting	Healthy Controls	Total
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
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%

Outcome Measures

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1. Primary Outcome

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

Outcome Measure Data

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
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
Description	Plasma concentration of LA
Time Frame	2 hours

Outcome Measure Data

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
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
Description	Plasma concentration of LA
Time Frame	3 hours

Outcome Measure Data

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
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
Description	Plasma concentration of LA
Time Frame	4 hours

Outcome Measure Data

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
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
Description	Plasma concentration of LA
Time Frame	24 hour

Outcome Measure Data

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
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
Description	Plasma concentration of LA
Time Frame	48 hour

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	2 hours

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	4 hours

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	24 hour

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	48 hour

Outcome Measure Data

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
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)

Adverse Events

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Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	MS - Secondary Progressive		MS - Relapsing Remmitting		Healthy Controls
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	--/--		--/--		--/--
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.
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

Limitations and Caveats

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[Not Specified]

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

EMail: 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. 2018 Jul;55(7):6037-6049. doi: 10.1007/s12035-017-0813-y. Epub 2017 Nov 15.

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