The effect of vitamin D supplementation on the gene expression of interleukins 10, 17A and 6 in the apparently healthy first degree relatives of multiple sclerosis patients compared to apparently healthy people.
The aim of this study is to investigate the effect of vitamin D supplementation on the Down/Up regulation of the components of See-Saw model in first degree relatives of Multiple sclerosis patients compared to the apparently healthy group. One of the study groups will consist of 23 first degree apparently healthy relatives of MS patients (such as son, daughter, sister and brother) and the other group is composed of 23 subjects who are free of any complication or genetic history ( no history of MS in their relatives). The participants should fulfil inclusion criteria including age between 20-40 years old and being satisfied with blood sampling, and shouldn’t have the exclusion criteria including malabsorption; consumption of medicine interacting with vitamin D; consuming vitamin D and Ca supplementation; pregnancy and lactation. The intervention in this study will be supplement therapy by vitamin D for 8 weeks, 50000 IU/week for both groups. Interleukins 6, 10 and 17A (levels of IL-6, IL-10, IL-17A) will be assessed in both groups as main outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703033655N3
Registration date:2017-03-28, 1396/01/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-28, 1396/01/08
Registrant information
Name
Seyed Rafi Arefhosseini
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1444 4782
Email address
arefhosseinir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
1-Tabriz University of Medical Sciences2-Ardabil University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-19, 1396/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on the gene expression of interleukins 10, 17A and 6 in the apparently healthy first degree relatives of multiple sclerosis patients compared to apparently healthy people.
Public title
The effect of vitamin D in the prevention of MS disease in first degree relatives of MS patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :the ability to give blood sample; tendency to take part in the study and filling FFQ and food record forms; having 20-40 years old. Exclusion criteria: having malabsorption; consumption of medicine that interact with Vitamin D absorption; catching chronic and immune system diseases; consumption of Ca & Vitamin D supplementation; pregnancy and lactation.
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave
City
Tabriz
Postal code
Approval date
2016-10-18, 1395/07/27
Ethics committee reference number
IR.TBZMED.REC.1395.780
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
Interleukin 10
Timepoint
twice: before and after intervention (after 2 months)
Method of measurement
by Real Time-PCR
2
Description
Interleukin 17A
Timepoint
twice: before and after intervention (after 2 months)
Method of measurement
by Real Time-PCR
3
Description
Interleukin 6
Timepoint
twice: before and after intervention (after 2 months)
Method of measurement
by Real Time-PCR
4
Description
25- hydroxy vitamin D level
Timepoint
twice: before and after intervention (after 2 months)
Method of measurement
by Electro Chemiluminescence
Secondary outcomes
1
Description
creatinine serum
Timepoint
twice: before and after intervention (after 2 months)
Method of measurement
by Enzymatic Method
Intervention groups
1
Description
Control group: supplement therapy by vitamin D for 8 weeks, 50000 IU/week.
Category
Prevention
2
Description
Intervention group: supplement therapy by vitamin D for 8 weeks, 50000 IU/week.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Genetic Lab, Ardabil University of Medical Sciences
Full name of responsible person
Dr.S Saied Hosseini-Asl
Street address
Daneshgah Ave
City
Ardabil
2
Recruitment center
Name of recruitment center
MS society of Ardabil province
Full name of responsible person
Sadegh Moharammzadeh
Street address
Sady St,
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Bahram Pourghassem
Street address
Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Dr.Shahram Habibzadeh
Street address
Daneshgah Ave
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Proportion provided by this source
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
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Syed Rafie Aref Hosseini
Position
PhD in nutrition biochemistry-Associate Professor
Other areas of specialty/work
Street address
Golgasht Ave
City
Tabriz
Postal code
Phone
+98 41333575813
Fax
Email
srarefhosseini@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences
Full name of responsible person
Dr.syyed Rafie Aref Hosseini
Position
Phd in nutrition biochemistry
Other areas of specialty/work
Street address
Golgasht Ave
City
Tabriz
Postal code
Phone
+98 41333575813
Fax
Email
srarefhosseini@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Hashemi
Position
Master Student
Other areas of specialty/work
Street address
No 602, Naderi settlements
City
Ardabil
Postal code
Phone
00
Fax
Email
rezahashemi60961@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)