Improving asthma treatment is the goal of this study.this is a randomized clinical trial in which 120 asthmatic 10-50 years old patient are divided randomly in 2 groups after confirming their asthma with spirometry and GINA protocol and ruling out any other chronic lung diseases in them.At the beginning their lung functions will be evaluated with spirometry and oscilometry and 3cc blood will be sampeled for tests.then they will prescribed their standard asthma treatment but case group will have vitamin D supplementation;100000units of vitamine D intra muscular and 50000units of Vit D oral weekly for 6 months plus their routine asthma treatment.if they have not find any asthma attack or use systemic corticosteroid they will be evaluated after 8 weeks and at the end of study again.the exams will be repeated.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201302079608N1
Registration date:2013-09-10, 1392/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-10, 1392/06/19
Registrant information
Name
Saba Arshi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66566101
Email address
s-arshi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin D supplementation on airways function and inflammation in 10-50 years old asthmaics in rasool e akram hospital
Public title
Vitamin D effects in asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 10-50;
Asthma diagnosis according to spirometry and GINA guidlines;
Ruled out of COPD and any chronic lung diseases;
No asthma attack in previous 3 months;
No pregnancy;
No malignancy; sarcoidosis; renal or intestinal diseases or hyper sensitivity to vitamin D;
No use of systemic corticoesteroid or anti convulsant
Exclusion criteria
No inclusion criteria;
No consent to this program
Age
From 10 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Tehran University of Medical Sciences
Street address
Corner of Ghods street, Keshavarz boulvard
City
Tehran
Postal code
-
Approval date
2012-10-12, 1391/07/21
Ethics committee reference number
19827
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
j45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Airway function
Timepoint
Before and after 8week, 16 week and after 6month
Method of measurement
Oscilometry
2
Description
Airway function
Timepoint
Before and after 8week, 16 week and after 6month
Method of measurement
Spirometry
3
Description
serum vitamin D level
Timepoint
Before and after 8week, 16 week and after 6month
Method of measurement
eliza (serum)
Secondary outcomes
1
Description
Serume Ig E level
Timepoint
before and after study
Method of measurement
ELIZA
Intervention groups
1
Description
Patient in the case group will receive appropriate Asthma controller according their Asthma stage which is inhaled oral corticosteroid with appropriate dose and extra than standard asthma treatment they will use vitamin D supplementation .they will inject 100000unit of Vit D intramuscular followed by 50000 unit Vit D orally weekly for 6 months.
Category
Treatment - Drugs
2
Description
Patients in the control group only receive asthma controller drug as oral inhaler corticosteroid according their asthma stage with appropriate dose without any supplementation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool e Akram Hospital
Full name of responsible person
Dr Morteza Fallahpour
Street address
Niayesh street, Sattar Khan street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research Division of Tehran University of Medical Sciences
Street address
Corner of Ghods Street, Keshavarz bulvard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Morteza Fallahpour
Position
Fellow of Allergy and Clinical Immunology
Other areas of specialty/work
Street address
Unit3, Nomber27, Siami Avenue, SattarKhan Street
City
Tehran
Postal code
-
Phone
+98 21 6692 8014
Fax
-
Email
fallahpour.morteza@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saba Arshi
Position
Assisted Professor
Other areas of specialty/work
Street address
unit 11, 7 street, Sarv Square, Saadat Abad
City
Tehran
Postal code
=
Phone
+98 21 2255 4933
Fax
-
Email
sabaarshi@yahoo.com
Web page address
=
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Fallahpour
Position
Fellow of Allergy and Clinical Immunology
Other areas of specialty/work
Street address
unit3, Number 28, Siami ave,Satar khan street
City
Tehran
Postal code
=
Phone
+98 21 6692 8014
Fax
Email
fallahpour.morteza@gmail.com
Web page address
=
Sharing plan
Deidentified Individual Participant Data Set (IPD)