The aim of this research is to investigate vitamin D effects on the expression of IL2,IL4,IL6,IL17A,CYP27A1 and CYP27B1in multiple sclerosis patients .
Therefore,45 relapsing-remitting multiple sclerosis patients with serum level vitamin D (80NG/ML) are selected and after taking their blood samples ,are administrated to the patients 50000IU of vitamin D per week for 8 weeks .The patients’ blood samples are taken after 8 weeks again .The expression of target genes will measure before and after treatment at mRNA level by Real Time PCR . Inclusion criteria: relapsing-remitting multiple sclerosis patients; MS patients with vitamin D deficiency (<80ng/ml). Exclusion criteria: patients treated with vitamin D supplements; progressive MS; relapsed patients, psychiatric patients and the patients who are taken steroid drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081818840N1
Registration date:2014-09-28, 1393/07/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-28, 1393/07/06
Registrant information
Name
Bahar Naghavi Gargari
Name of organization / entity
Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4477
Email address
bahar.naghavigargari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares university
Expected recruitment start date
2012-09-23, 1391/07/02
Expected recruitment end date
2013-09-24, 1392/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effects of vitamin D on IL2,IL4, IL-6 ,IL-17A,CYP27A1 and CYP27B1 genes expression in multiple sclerosis patients
Public title
Study of effects of vitamin D on some genes expression in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: relapsing-remitting multiple sclerosis patients; MS patients with vitamin D deficiency (<80ng/ml). Exclusion criteria: patients treated with vitamin D supplements; progressive MS; relapsed patients, psychiatric patients and the patients who are taken steroid drugs.
Age
From 22 years old to 52 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University
Street address
school of Medicine, Tarbiat Modares University, Nasrbrigs, Tehran, Islamic Republic of Iran
City
Tehran
Postal code
Approval date
2014-05-31, 1393/03/10
Ethics committee reference number
52/1632/d
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
expression of IL2 gene
Timepoint
before vitamin D treatment and two month after treatment
Method of measurement
taking of blood from patients and measurment of mRNA level
Secondary outcomes
1
Description
expression of IL4 ,IL6,IL17A,CYP27A1 and CYP27B1
Timepoint
before vitamin D treatment and two month after treatment
Method of measurement
taking of blood from patients and measurement of mRNA level
Intervention groups
1
Description
vitamin D, 50000 IU /a week , 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Research Center
Full name of responsible person
Dr. Roozita Doosti
Street address
City
Terhran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor forTarbiat Modares University of Tehran
Full name of responsible person
Dr. Mehrdad Behmanesh
Street address
Genetic Department,Faculty of biological Science, Tarbiat Modares University, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor forTarbiat Modares University of Tehran
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
Tarbiat Modares University
Full name of responsible person
Bahar Naghavi Gargari
Position
phd student
Other areas of specialty/work
Street address
Genetic Department,Faculty of Bilogical Science, Tarbiat Modares university
City
Tehran
Postal code
Phone
+98 21 8288 4477
Fax
+98 21 8288 4478
Email
bahar.naghavigargari@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Dr.Mehrdad Behmanesh
Position
Associate
Other areas of specialty/work
Street address
Genetic Department,Faculty of Biological Science, Tarbiat Modares University, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8288 4451
Fax
Email
behmanesh@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohamad Ali Sahraian
Position
Specialist
Other areas of specialty/work
Street address
MS Research Center, Sina hospital
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)