Objectives: to determine the effect of vitamin D on the Frequency of asthma Exacerbation, the effect of vitamin D on S-IgE levels in serum of patients with asthma, the effect of vitamin D on FEV1 in patients with asthma, and the effect of vitamin D on the quality of life of patients with asthma. Design:This study is a clinical trial study that is randomized as Balanced Block randomizations. Setting and conduct: َAsthmatic patients questionnaire included demographic information, clinical symptoms and laboratory tests is completed after obtaining the consent of the parents of the patients enrolled. They will be treated for 3 months according to the protocol, patients will be visited monthly. After 4 to 6 months of treatment, spirometry and positive laboratory tests will be repeated. Participants: children with mild to moderate asthma visited in asthma and allergy clinic afflicted to Children's Medical Center. Inclusion criteria’s: 1- Patients with mild to moderate asthma diagnosed by physician2 - Patients who are less than 3 months of treatment over the past 3 - patients between 6-14 years old; Exclusion criteria: 1 - Patients with severe asthma 2 - patient treated with immunotherapy or anti IgE 3 - Patients with chronic diseases like cardiovascular disease. Intervention: Vitamin D supplementation for 3 months + spray Fluticasone; control: spray Fluticasone as standard treatment of asthma. Main outcome measures:FEV1, FEV1/FVC, QOL, ACT
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110127784N1
Registration date:2012-12-01, 1391/09/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-01, 1391/09/11
Registrant information
Name
Behzad Darabi
Name of organization / entity
Tehran Univesity of medical siences
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 9875
Email address
darabibh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Immunology, Asthma and Allergy Research Institute
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamin D supplementation over mild to moderate asthma outcome in 6-14 years old children
Public title
The effect of Vitamin D supplementation over mild to moderate asthma outcome in 6-14 years old children
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:1- Patients with mild to moderate asthma diagnosed by physician2 - Patients who are less than 3 months of treatment over the past 3 - patients between 6-14 years old; Exclusion criteria: 1 - Patients with severe asthma 2 - patients treated with immunotherapy or anti IgE 3 - Patients with chronic diseases like cardiovascular disease
Age
From 6 years old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
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 Tehran university of medical sciences
Street address
6th floor,University Central Association,Keshavarz Blvd,Tehran
City
Tehran
Postal code
Approval date
2012-03-17, 1390/12/27
Ethics committee reference number
130.2455.د.90
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Nonallergic asthma
2
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Mixed asthma
3
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Predominantly allergic asthma
Primary outcomes
1
Description
FEV1
Timepoint
before and 4-6 months after intervention
Method of measurement
spirometry
2
Description
FEV1/FVC
Timepoint
before and 4-6 months after intervention
Method of measurement
spirometry
3
Description
Quality of life
Timepoint
before and 4-6 months after intervention
Method of measurement
Questionnaire
4
Description
Asthma control
Timepoint
before and 4-6 months after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
S-IgE
Timepoint
before and 4-6 months after intervention
Method of measurement
RIDA
Intervention groups
1
Description
intervention: Vitamin D supplementation 500 U per day for 3 months + spray Fluticasone 100-500 microgram per day
Category
Treatment - Drugs
2
Description
control: spray Fluticasone 100-500 microgram per day as standard treatment of asthma
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
children medical center
Full name of responsible person
Behzad Darabi
Street address
NO.62 Gharib St, Keshavarz Blvd,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Immunology, Asthma and Allergy Research Institute
Full name of responsible person
Mostafa Moin MD
Street address
O.62 Gharib St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Immunology, Asthma and Allergy Research Institute
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
Allergy and clinical immunology unit,Centeral Medical Center
Full name of responsible person
Behzad Darabi MD
Position
Allergy and clinical immunology fellowship
Other areas of specialty/work
Street address
NO.62 Gharib St, Keshavarz Blvd
City
Tehran
Postal code
14194
Phone
009821:66920981-3
Fax
+98 21 6693 0024
Email
arabibh@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Univesity of medical siences
Full name of responsible person
Mostafa Moin MD
Position
professor
Other areas of specialty/work
Street address
Asthma and Clinical Immunology unit,NO.62 Gharib St, Keshavarz Blvd
City
Tehran
Postal code
0098 21 66930024
Phone
+98 21669209813
Fax
+98 21 6642 8995
Email
iaari@tums.ac.ir
Web page address
www.iaari.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences, Children Medical Center,Allergy and clinical immunology unit
Full name of responsible person
Behzad Darabi
Position
Allergy and clinical immunology fellowship
Other areas of specialty/work
Street address
Asthma and Clinical Immunology unit,NO.62 Gharib St, Keshavarz Blvd
City
Tehran
Postal code
14194
Phone
+98 21669209813
Fax
+98 21 6693 0024
Email
darabibh@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)