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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00997438

Enrollment

Registered

2009-10-19

Start date

2010-08-31

Completion date

2013-12-31

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

The purpose of this study is to learn about how the antioxidant, lipoic acid, works in the body and how it may help in the management of relapsing remitting and secondary progressive multiple sclerosis. This study will compare how subject's and healthy volunteers bodies absorb and break down the supplement. This information may help in developing new therapies.

Detailed description

Subjects (healthy control, relapsing remitting MS and secondary progressive MS) will be recruited through patients of investigators at Portland VA Medical Center (PVAMC), Oregon Health & Science University (OHSU), and the community using flyers and word of mouth. The following will occur during screening: * Medical History Questionnaire to include questions about drug and alcohol use * Self Administered Expanded Disability Status Scale (EDSS) Questionnaire (MS participants only) * Vital Signs (heart rate, respiratory rate, blood pressure) will be measured and recorded * Physical Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety) * Neurological Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety) * Weight * Urine pregnancy test, if applicable * Anemia testing by finger stick (approximately 1 drop) The rest of the study involves * Blood draws before lipoic acid is given, 1 hour, 2 hours, 3 hours, 4 hours, 24 and 48 hours after LA is given (3 ½ tablespoons) * Subjects will receive breakfast before they take LA * Subjects will take 4 - 300 mg capsules of lipoic acid (LA) for a total of 1200mg with about 1 cup of water Blood will be processed to obtain plasma (from which lipoic acid concentrations will be measured) and PBMCs (from which cAMP and cytokines/chemokines will be measured).

Interventions

DIETARY_SUPPLEMENTLipoic Acid

300 mg Lipoic acid tablets from Vital Nutrients

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Inclusion/

Exclusion criteria

for MS subjects. Inclusion criteria: 1. Adult at least 18 years of age able to provide informed consent 2. Currently diagnosed with relapsing remitting or secondary progressive MS

Design outcomes

Primary

Measure	Time frame	Description
Lipoic Acid Levels	1 hour	Plasma concentration of LA
cAMP Levels	2 hours	—

Secondary

Measure	Time frame
RANTES Levels	24 hour

Countries

United States

Participant flow

Recruitment details

Recruited at PVAMC and OHSU January 2012-December 2013 via fliers, word of mouth and MS clinic screening.

Participants by arm

Arm	Count
MS - Secondary Progressive 1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients	16
MS - Relapsing Remmitting 1200mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients	21
Healthy Controls 1200 mg of Lipoic acid supplement Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients	20
Total	57

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Blood draw difficulty	2	0	1
Overall Study	Exclusion criteria at visit 1	2	2	3
Overall Study	Withdrawal by Subject	1	1	0

Baseline characteristics

Characteristic	MS - Secondary Progressive	MS - Relapsing Remmitting	Healthy Controls	Total
Age, Continuous	57.5 years	51 years	49.5 years	54 years
Gender Female	10 Participants	14 Participants	12 Participants	36 Participants
Gender Male	6 Participants	7 Participants	8 Participants	21 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 21	1 / 24	0 / 24
serious Total, serious adverse events	0 / 21	0 / 24	1 / 24

Outcome results

Primary

cAMP Levels

Time frame: 2 hours

Population: Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients

Arm	Measure	Value (MEDIAN)
MS - Secondary Progressive	cAMP Levels	75.9 pmol cAMP/mg protein
MS - Relapsing Remmitting	cAMP Levels	75.8 pmol cAMP/mg protein
Healthy Controls	cAMP Levels	96.6 pmol cAMP/mg protein

Primary

cAMP Levels

Time frame: 4 hours

Population: Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients

Arm	Measure	Value (MEDIAN)
MS - Secondary Progressive	cAMP Levels	72.6 pmol cAMP/mg protein
MS - Relapsing Remmitting	cAMP Levels	79.1 pmol cAMP/mg protein
Healthy Controls	cAMP Levels	103.5 pmol cAMP/mg protein

Primary