Treg/Th17 axis : the impact of vitamin D supplementation on TGF-β and IL-17A balance and mRNA expression in Multiple Sclerosis patients compared to apparently healthy first degree relatives of patients and apparently healthy people.
comparison of vitamin D supplementation on expression of IL-17A and TGF-B genes in multiple sclerosis (MS) patients, apparently healthy first degree relatives of patients and apparently healthy people.
Design
This study is controlled by vitamin D which intervention group will consist of 25 MS patints, while the control groups will include 25 apparently healthy first degree relatives of MS patients (such as son, daughter, sister and brother) and 25 apparently healthy subjects who are free of any complication or genetic history (no history of MS in their relatives). 25 people for each group out of all participants that will meet all inclusion criteria will randomize through simple random sampling. Allocating to each group will be through lottery and random paper which have been concealed in draw balls.
Settings and conduct
Whole blood samples (10 ml) will obtain from the participants before and after the trial and the serum levels of 25-(OH) vitamin D3 will measure using Electro Chemiluminescence (ECL) assay. Then, total RNA will extract and followed by total RNA, cDNA synthesis will do. Real-time PCR will perform using primers specific for TGF-B, IL-17A, along with β-actin as a housekeeping control.
Participants/Inclusion and exclusion criteria
Inclusion: 1.The ability to give blood sample; 2.Tendency to take part in the study; 3.having 20-40 years old; 4.Verifying MS diseases by a neurologist expert.
Exclusion: 1.Having malabsorption; 2.Consumption of medicine that interact with Vitamin D absorption; 3.Catching chronic and immune system diseases; 4.Consumption of Ca & Vitamin D supplementation; 5.pregnancy and lactation
Intervention groups
The intervention in this study will be administrated by vitamin D for 8 weeks, 50000 IU/week for three groups.
Main outcome variables
Interleukins 17A and TGF-B will be assessed in all of three groups as a main outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100407003655N4
Registration date:2018-11-02, 1397/08/11
Registration timing:prospective
Last update:2018-11-02, 1397/08/11
Update count:0
Registration date
2018-11-02, 1397/08/11
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
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treg/Th17 axis : the impact of vitamin D supplementation on TGF-β and IL-17A balance and mRNA expression in Multiple Sclerosis patients compared to apparently healthy first degree relatives of patients and apparently healthy people.
Public title
Affecting of vitamin D administration on mRNA expression of Treg/Th17 axis.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The ability to give blood sample
Tendency to take part in the study
having 20-40 years old
Verifying MS diseases by a neurologist expert
No receiving of vitamin D supplementation in the last 2 months
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:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Twenty-five people for each group out of all participants that will meet all inclusion criteria will randomize through simple random sampling. Allocating to each group will be through lottery and random paper which have been concealed in draw balls.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2018-10-22, 1397/07/30
Ethics committee reference number
IR.TBZMED.REC.1397.608
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
IL-17A
Timepoint
Before and After supplementation
Method of measurement
Real time - PCR
2
Description
TGF-B
Timepoint
Before and After supplementation
Method of measurement
Real time - PCR
3
Description
Vitamin D
Timepoint
Before and After supplementation
Method of measurement
ECL
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Other
2
Description
Control group:
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Reza Hashemi
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3357 5803
Email
rezahashemi60961@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Tarighat
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3357 5803
Email
tarighata@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
seyed Rafie Arefhosseini
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41133575803
Email
arefhosseinir@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Hashemi
Position
student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41133575803
Email
rezahashemi60961@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Hashemi
Position
student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41133575803
Email
rezahashemi60961@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
only IPD collected for the primary outcome measure.
When the data will become available and for how long
after publication will start.
To whom data/document is available
available for people working in academic institutions
Under which criteria data/document could be used
this is not include especial criteria
From where data/document is obtainable
sending email to corresponding author
What processes are involved for a request to access data/document
after receiving email and coordinating with other colleagues, the demanded documents will be available.