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Study the effect of vitamin D on the activity of T-regulator cell and Th17 and its association with clinical symptoms of patients with idiopathic chronic urticaria

Protocol summary

Summary
The aim of this study was to evaluate the effect of vitamin D in the treatment of chronic idiopathic urticaria and its immunological changes. This pilot trial was performed on 20 patients with chronic idiopathic urticaria before and after treatment without any control group. Chronic idiopathic urticarial patients with rejection of other possible causes of chronic urticaria by interview, allergy test and blood test with serum level 25 OH vit D less than 10 ng / ml enter the trial. The study was conducted with the help of an allergist and PhD Immunology as a single center of the Aliergy Clinic of Ghaem Hospital in Mashhad. This study has been done in Phase 3 and not blinded inclusion Criteria are getting chronic urticaria scheme more than 6 weeks, rejection of allergenes, patient satisfaction, and serum levels of 25 OH vit D should be less than 10 ng / ml, and exclusion criteria are the presence of various types of allergic diseases in the patient, corticosteroid drug usage, Autoimmune and immunodeficiency disease, normal levels of vitamin D.The main Outcome are assessment the quality of life with DLQI questionnaire, idiopathic utricaria severity based on USS questionnaire, TGF-β gene expression, IL-10 gene expression, IL-17 gene expression , FOXP3 gene expression

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092123235N12
Registration date: 2017-10-24, 1396/08/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
Farahzad Jabbari Azad
Name of organization / entity
Allergy Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2770
Email address
jabbarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of vitamin D on the activity of T-regulator cell and Th17 and its association with clinical symptoms of patients with idiopathic chronic urticaria
Public title
Study the effect of vitamin D on the symptoms of urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Chronic urticaria affected for more than 6 weeks, negative skin Prick test for common respiratory allergens. Patient's willingness to take medication and participate, The serum level of 25 OH vit D Should be less than 10 ng / ml Exclusion criteria: taking Corticosteroid drug during the past week. having Other allergic diseases and Infectious diseases and Autoimmune disease Normal levels of vitamin D
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The trial phase is 3 as this project worked on human subjects

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashahd University of Medical Sciences
Street address
Ghoreish building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2013-09-11, 1392/06/20
Ethics committee reference number
IR.MUMS.REC.1392.154

Health conditions studied

1

Description of health condition studied
Idiopathic chronic urticaria
ICD-10 code
L50.8
ICD-10 code description
Other urticaria

Primary outcomes

1

Description
Quality of life
Timepoint
Befor the trial
Method of measurement
DLQI Questionnaire

2

Description
Utricaria severity
Timepoint
Befor the trial
Method of measurement
USS Questionnaire

Secondary outcomes

1

Description
IL-17 Exprssion
Timepoint
After the trial
Method of measurement
Real-time PCR

2

Description
IL-10 Exprssion
Timepoint
After the trial
Method of measurement
Real-time PCR

3

Description
TGF-B Expression
Timepoint
After the trial
Method of measurement
Real-time PCR

4

Description
Foxp3 expression
Timepoint
After the trial
Method of measurement
Real-time PCR

Intervention groups

1

Description
every 10 days, 1 tablet of 50,000 units of vitamin D is given to the patient.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Allergy Clinic Ghaem Hospital
Full name of responsible person
Reza Farid Hosseiny
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Ghoreishi Building, Daneshgah Ave, mashhad
City
Mshhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shima Zarei
Position
Msc of Immunology
Other areas of specialty/work
Street address
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
arc@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Farahzad Jabbari Azad
Position
subspecialist of Immunology and Allergy
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 518012770
Fax
Email
jabbarif@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Farid Hosseiny
Position
Professor
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
00
Fax
Email
arc@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
empty
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