Protocol summary

Summary
The aim of this study is to investigate the effect of lipoic acid supplementation on serum level of lipoic acid, inflammation and antioxidant factors in multiple sclerosis patients. In this parallel randomized controlled trial, 60 men and women with multiple sclerosis will be recruited from center of multiple sclerosis of Sina hospital of Tehran university of medical science. Inclusion criteria are adults 18-51 years old, able to provide informed consent and diagnosed with relapsing remitting MS. Exclusion criteria are: MS exacerbation during of study, systemically administered corticosteroids during the study, pregnant or breast-feeding, other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus and other autoimmune disease) that might increase the risk of subject experiencing adverse events; consumption of vitamin, mineral and antioxidant supplement 30 days before study entry, any condition which would make the subject, in the opinion of the investigator, unsuitable for the study and compliance less than 70%. Prior to the study, the subjects will be required to complete 3-days 24-hour dietary recall. Diets will be analyzed for calorie and macronutrients and copper, iron, zinc and manganese content. Intervention group receives 1200 mg of lipoic acid as 2 capsules and other group receives 2 placebo capsules. Blood samples will be obtained after an overnight fast before and after the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812222602N2
Registration date: 2010-03-13, 1388/12/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-03-13, 1388/12/22
Registrant information
Name
Shahryar Eghtesadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
egtesadi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Iran university of Medical Sciences
Expected recruitment start date
2010-09-02, 1389/06/11
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lipoic acid on antioxidant factors, Th1/Th2 balance and clinical signs in multiple sclerosis patients
Public title
Effects of lipoic acid on inflammation and antioxidant factors in multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18-51 years, able to provide informed consent and diagnosed with relapsing remitting MS. Exclusion criteria: MS exacerbation during the study, systemically administered corticosteroids during the study , pregnant or breast-feeding , other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus and other autoimmune disease) that might increase the risk of subject experiencing adverse events. Consumption of vitamin, mineral and antioxidant supplement 30 days before study entry, Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study and compliance less than 70%.
Age
From 18 years old to 51 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Health, Iran University of Medical Sciences
Street address
Alvand Ave, Arjanteen Square
City
Tehran
Postal code
Approval date
2010-07-19, 1389/04/28
Ethics committee reference number
1421

Health conditions studied

1

Description of health condition studied
muiltiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
decrease serum lipoic acid concentration
Timepoint
12 week
Method of measurement
HPLC

2

Description
decrease serum TNF-a concentration
Timepoint
12 week
Method of measurement
labratory kit

3

Description
decrease serum MDA concentration
Timepoint
12 week
Method of measurement
Spectrophotometry

4

Description
increase SOD
Timepoint
12 week
Method of measurement
Spectrophotometry

5

Description
increase glutathione peroxidase
Timepoint
12 week
Method of measurement
Spectrophotometry

6

Description
decrease serum ADA concentration
Timepoint
12 week
Method of measurement
ELYSA

7

Description
decrease serum INF-y concentration
Timepoint
12 week
Method of measurement
ELYSA

8

Description
increase TGF-B
Timepoint
12 week
Method of measurement
ELYSA

9

Description
increase IL-6
Timepoint
12 week
Method of measurement
ELYSA

10

Description
increase IL-4
Timepoint
12 week
Method of measurement
ELYSA

11

Description
decrease MMP-9
Timepoint
12 week
Method of measurement
ELYSA

12

Description
decrease VCAM-1
Timepoint
12 week
Method of measurement
ELYSA

13

Description
decrease ICAM-1
Timepoint
12 week
Method of measurement
ELYSA

14

Description
TAC
Timepoint
12 week
Method of measurement
colorimetry

Secondary outcomes

1

Description
decrease EDSS
Timepoint
12 week
Method of measurement
observation

Intervention groups

1

Description
lipoic acid supplement (1200mg/day) for 90 days
Category
Treatment - Drugs

2

Description
control group: 2 capsuls including dietary fiber
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
MS research ceter of Sina hospital
Full name of responsible person
Mohamad Ali Sahraian
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohsen Asadi Lari
Street address
Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Health, Iran University of Medical Sciences
Full name of responsible person
Dr. Shahriar Eghtesadi
Position
Full Professor
Other areas of specialty/work
Street address
School of Health, Alvand Ave, Arjanteen Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
egtesadi@iums.ac.ir, egtesadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Health, Iran University of Medical Sciences
Full name of responsible person
Dr Shahriar Eghtesadi
Position
Full Professor
Other areas of specialty/work
Street address
School of Health, Alvand Ave, Arjanteen Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
egtesadi@iums.ac.ir, eghtesadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Shahriar Eghtesadi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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