The goal of this study the effect of vitamin D on the expression TGF-βI, TGF-βII, TGF-β RI, TGF-β RII, NFĸB1 and IL-10 genes in patients with multiple sclerosis will be reviewed. Therefore, 45 relapsing-remitting multiple sclerosis patients who have lower than normal levels of serum vitamin D (80NG/ML) are selected and their blood samples were taken and 50000IU of vitamin D per week for 8 weeks for they are prescribed. Eight weeks after patients received vitamin D blood sample is taken again. The expression of target genes at the level of mRNA extracted from the blood of patients before and after treatment will check Real Time PCR.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011216181N1
Registration date:2014-03-14, 1392/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-14, 1392/12/23
Registrant information
Name
Zeinab Shirvani Farsani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4477
Email address
z.shirvani@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares university of Tehran
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 expression of TGF-βI, TGF-βII, TGF-β RI, TGF-β RII, NFĸB1 and IL-10 genes in Multiple Sclerosis patient
Public title
Study of Effects of Vitamin D on expression of some of genes in MS patient
Purpose
Basic scienece
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.
Age
From 20 years old to 55 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
Nasr bridgs - Trabiat Modares University- School of Medicine
City
Tehran
Postal code
Approval date
2014-02-08, 1392/11/19
Ethics committee reference number
52/6723d
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 IL10 gene
Timepoint
before vitamin D treatment and two month after treatment
Method of measurement
obtain of blood from patients and measurment of mRNA level
2
Description
expression of TGF-B1 gene
Timepoint
before vitamin D treatment and two month after treatment
Method of measurement
obtain of blood from patients and measurement of mRNA level
3
Description
expression of TGF-B2, TGF-B receptor I, TGFB receptor II, NF-KB, VDR gene
Timepoint
before vitamin D treatment and two month after treatment
Method of measurement
obtain of blood from patients and measurement of mRNA level
4
Description
serum vitamin D
Timepoint
before vitamin D treatment and two month after treatment
Method of measurement
obtain of blood from patients and measurement of serum vitamin D level
Secondary outcomes
empty
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
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University of Tehrean
Full name of responsible person
Dr. Mehrdad Behmanesh
Street address
Genetic Department,Faculty of 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
Tarbiat Modares University of Tehrean
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 of Tehran
Full name of responsible person
Mehrdad Behmanesh
Position
Associate
Other areas of specialty/work
Street address
Genetic Department,Faculty of 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 scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Mehrdad Behmanesh
Position
Associate
Other areas of specialty/work
Street address
Genetic Department,Faculty of 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
Mohamad Ali Sahraian
Position
specialist
Other areas of specialty/work
Street address
Sina Hospital- MS Research Center
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)