Aim of this study was evaluating the effects of vitamin D in patients with atopic dermatitis, and assessing its efficacy and capability on immune response modulating.
Design
The Clinical trial with community-based and pragmatic control group, parallel groups,randomized with number table. not blinded and the intervention was conducted in Phase 3 on 20 subjects in each group (intervention and control) for 2 months, they gave one tablet or drops of vitamin D1000 units daily.
Settings and conduct
This study was conducted on the effect of vitamin D in controlling atopic dermatitis in patients with vitamin D deficiency who referred to the Allergy clinic of Ghaem Hospital of Mashhad University of Medical Sciences and compared with control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients up to 50 years old who have clinical signs of atopic dermatitis
2. Low serum vitamin D levels
3. No oral drug for controlling atopic dermatitis recently
Exclusion criteria:
1- Patients with other atopic diseases
2 Having skin infections
Intervention groups
In the case group, 20 patients with atopic dermatitis with vitamin D deficiency (<30 mg/dl) were given daily for 2 months a tablet or drops of vitamin D1000 unit with the combination of 1-alpha-hydroxycholecalciferol from Vitabothic company . In the control group, 20 people without allergy and skin disease with a shortage of vitamin D (less than 30 mg / dl) received daily for 2 months a pill or drops of vitamin D1000 unit with the combination of 1-alpha-hydroxycholecalciferol from the Vitabothic company .
Main outcome variables
Changing the clinical symptoms of patients with atopic dermatitis based on scorad questionnaire and changes in the frequency of T reg cells in the peripheral blood by flow cytometry
General information
Reason for update
Acronym
درماتیک آتوپیک
IRCT registration information
IRCT registration number:IRCT20150716023235N13
Registration date:2018-11-02, 1397/08/11
Registration timing:retrospective
Last update:2018-11-02, 1397/08/11
Update count:0
Registration date
2018-11-02, 1397/08/11
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
Expected recruitment start date
2017-09-02, 1396/06/11
Expected recruitment end date
2018-03-17, 1396/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness of vitamin D in Treg cell frequency in atopic dermatitis and control group
Public title
Evaluation of Effectiveness of vitamin D on immunity of atopic dermatitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients up to 50 years old who have clinical signs of atopic dermatitis
Low serum vitamin D levels
No oral drug for controlling atopic dermatitis recently
Exclusion criteria:
Patients with other atopic diseases
Having skin infections
Age
From 1 month old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method with random number table was used.
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 Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2017-12-20, 1396/09/29
Ethics committee reference number
IR.MUMS.fm.REC.1396.607
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20.8
ICD-10 code description
Other atopic dermatitis
Primary outcomes
1
Description
Clinical symptoms of atopic dermatitis
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of the consumption
Method of measurement
SCORAD questionnaire
2
Description
Frequency of T reg cells in the blood
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of the consumption
Method of measurement
Flowcytometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For patients with atopic dermatitis, for a period of 2 months, one tablet or drops of vitamin D1000 unit was given by the combination of 1-alpha-hydroxycholecalciferol from Vitabothix company.
Category
Treatment - Drugs
2
Description
Control group: 20 healthy people from the point of allergies, atopy and skin diseases received one tablet or drops of vitamin D1000 unit for 2 months,from the combination of 1-alpha-hydroxycholecalciferol from Vitabothix company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy clinic of Ghaem Hospital
Full name of responsible person
Farahzad Jabbari Azad
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2770
Email
Jabbarif@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreishi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Payam Payandeh
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Ahmadabad AVE Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2770
Email
dr.payandeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farahzad Jabbari Azad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Ahmadabad AVE Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2770
Email
jabbarif@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farahzad Jabbari Azad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 218012753
Email
Jabbarif@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available