Evaluation of gluten-free diet on Chronic Urticaria in 25 patients referred to the Dermatology Clinic of Hospitals of Islamic Azad University of Medical Sciencs-Tehran Unit.
Design
Non-randomized clinical trial with concurrent parallel study, controlled group trial, not-blinded and available patients.
Settings and conduct
In this Interventional study, clinical trial, which is performed as a concurrent parallel study, 50 Chronic Urticaria patients referred to dermatology clinic of Islamic Azad University of Tehran Medical Branch during the years 2016 and 2017 were selected and investigated. They were divided into two almost similar groups contains 25 patients. Gluten-free diet for one of group, and Placebo (vitamin B1 100 mg daily) was ordered for one month for another group. Both groups were followed weekly during a one month period. Then they were evaluated for response to treatment at the end of the month. In this way, the effectiveness of gluten-free diet was evaluated for their disease recovery.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1- The patient's availability for follow-up for one month
2- Possibility to examine the skin with chronic urticaria
3- Chronic urticaria
4- Mild to moderate chronic urticaria
5- Age over 15 years
6- Age under 65 years
No Entry- criteria:
1- Chronic physical urticaria
2- Severe chronic urticaria (frequent recurrence, generalized)
3- Chronic urticaria associated with dyspnea and/ or angioedema
Intervention groups
Intervention groups. Gluten-free diet for one of Intervention group, and Placebo (vitamin B1 100 mg daily) was ordered for one month for another group.
Main outcome variables
Clinical improvement of Chronic urticaria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180421039374N1
Registration date:2018-10-07, 1397/07/15
Registration timing:retrospective
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Shiva Bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3334 8269
Email address
sh.bahrami@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2016-08-22, 1395/06/01
Actual recruitment end date
2017-09-23, 1396/07/01
Trial completion date
2017-09-23, 1396/07/01
Scientific title
Evaluation of gluten-free diet effect on chronic urticaria
Public title
Effect of gluten-free diet on chronic urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic urticaria
Possibility to examine the skin with chronic urticaria
Mild to moderate chronic urticaria
Age over 15 years
Age under 65 years
The patient's availability for follow-up for one month
Exclusion criteria:
Chronic physical urticaria
Severe chronic urticaria (frequent recurrence, generalized)
Chronic urticaria associated with dyspnea and/ or angioedema
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Islamic Azad University, Tehran Medical Branch
Street address
Tehran Medical Branch , Islamic Azad UniversityT, khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2016-08-16, 1395/05/26
Ethics committee reference number
IR.IAU.TMU.REC.1395.166
Health conditions studied
1
Description of health condition studied
Chronic urticaria
ICD-10 code
L50.8
ICD-10 code description
Other urticaria
Primary outcomes
1
Description
Clinical improvement of Chronic urticaria
Timepoint
Clinical evaluation of the severity of urticaria in the beginning of the study and 7, 14, 21 and 30 days after gluten-free diet
Method of measurement
Clinical observation of urticaria and patient inquiries
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: gluten-free diet (remove wheat, barley, cloves and food from them) for one month.
Category
Treatment - Other
2
Description
Control group: placebo, tablet vitamin B1 ,100 mg,daily for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al-momenin hospital
Full name of responsible person
Mahmood Amerion
Street address
Amir al-momenin hospital, shirmohammadi St., Naziabad
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6262
Fax
+98 21 5534 6301
Email
info@amhos.ir
Web page address
http://amhos.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Tehran Medical Branch , Islamic Azad UniversityT, khaghani St., shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
iautmu@iautmu.ac.ir
Web page address
http://iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Shiva Bahrami
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran Medical Branch , Islamic Azad UniversityT, Khaghani St., Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
sh.bahrami@iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Setareh Tehrani
Position
استادیار
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tehran Medical Branch, Islamic Azad UniversityT, Khaghani St, Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
s.tehrani@iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shiva Bahrami
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran Medical Branch, Islamic Azad UniversityT, Khaghani St., Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
sh.bahrami@iautmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared with unidentifiable patients.
When the data will become available and for how long
Start the access period: 12 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Analysis of data in related research
From where data/document is obtainable
Corresponding author: sh.bahrami@iautmu.ac.ir and sh.bahrami7@gmail.com
What processes are involved for a request to access data/document