Protocol summary

Summary
The aim of this study is to investigate the effect of coenzyme Q10 supplementation on serum level of antioxidant factors in multiple sclerosis patients. In this parallel randomized controlled trial, 50 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 500 mg of coenzyme Q10 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: IRCT138905172602N4
Registration date: 2011-08-05, 1390/05/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-08-05, 1390/05/14
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 Tehran university of Medical Sciences
Expected recruitment start date
2011-09-21, 1390/06/30
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of coenzyme Q10 on inflammatory factors in multiple sclerosis patients.
Public title
Effect of Q10 on multiple sclerosis patients
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
3
Groups that have been masked
No information
Sample size
Target sample size: 50
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, Tehran University of Medical Sciences
Street address
Alvand Ave, Arjanteen Square
City
Tehran
Postal code
Approval date
2011-05-10, 1390/02/20
Ethics committee reference number
90/د/130/518

Health conditions studied

1

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

Primary outcomes

1

Description
TGF-B
Timepoint
12 weeks after the intervention
Method of measurement
ELISA

2

Description
serum TNF-a concentration
Timepoint
12 weeks after the intervention
Method of measurement
labratory kit

3

Description
IL-4
Timepoint
12 weeks after the intervention
Method of measurement
ELYSA

4

Description
IL-6
Timepoint
12 weeks after the intervention
Method of measurement
ELISA

5

Description
MMP-9
Timepoint
12 weeks after the intervention
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Q10 supplement (500mg/day) for 90 days
Category
Treatment - Drugs

2

Description
Control group: 2 capsules/day including dietary fiber
Category
Placebo

Recruitment centers

1

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran 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
Tehran 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, tehran 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 scientific inquiries

Contact
Name of organization / entity
School of Health, tehran 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 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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