This is a randomized clinical trial aimed to investigate the effect of vitamin D supplement on airway function in mild and moderate asthma with vitamin D deficiency on 40 patients referring pulmonology clinic of Ali Ebne Abi Taleb hospital in Zahedan. Inclusion criteria are age of 15-50 years, having mild or moderate asthma, having a vitamin D level less than 30 ng/ml and exclusion criteria are having a chronic obstructive pulmonary disease, using vitamin D supplement, having renal or hepatic failure, pregnancy or lactation and treatment with anti-epileptic drugs. In asthmatic patients referring the clinic, vitamin D level will be measured and those with a level less than 30 ng/ml will be included in the study. After including 40 patients in the study, they will be randomly divided into two equal groups, vitamin D receivers and placebo group. Patients in both groups will receive their asthma controlling drugs and vitamin D group will receive oral vitamin D supplement 50000 I/U per week for 8 weeks and placebo group will receive a placebo. All the patients will be followed for 24 weeks and will be assessed for asthma attack, conversion to severe asthma and emergency visits and finally, the data will be compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112731129N1
Registration date:2017-02-19, 1395/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Ahmad Ghoba
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
dr.ghoba@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of vitamin D supplement on airway function in mild
to moderate asthma with vitamin D deficiency in 2016-2017
Public title
The effect of vitamin D supplement on airway function in asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 15-50 years; having mild or moderate asthma; having a vitamin D level less than 30 ng/ml.
Exclusion criteria: having a chronic obstructive pulmonary disease; using vitamin D supplement; having renal or hepatic failure; pregnancy or lactation; treatment with anti-epileptic drugs.
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
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
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.ZAUMS.REC.1395. 138
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
asthma attack and conversion to severe asthma
Timepoint
1 monthly
Method of measurement
visiting by the study author
Secondary outcomes
empty
Intervention groups
1
Description
Vitamin D group: oral vitamin D supplement 50000 I/U per week for 8 weeks
Category
Treatment - Drugs
2
Description
Placebo group: placebo, oral tablet, once a week for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebne Abi Taleb Hospital
Full name of responsible person
Ahmad Ghoba
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdoost
Street address
Deputy of research and technology, Zahedan University of Medical Sciences campus, Jannat Blv, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Ahmad Ghoba
Position
Internal medicine resident
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3322 5715
Fax
+98 54 3322 5715
Email
dr.ghoba@yahoo.com, dr.ghoba@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nezarali Muolai
Position
Associate Professor
Other areas of specialty/work
Street address
Ali ebne Abi Taleb Hospital, Khalije Fars Blv, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3322 5715
Fax
+98 54 3322 5715
Email
Nezarali-muolai@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ahmad Ghoba
Position
Internal medicine resident
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3322 5715
Fax
Email
dr.ghoba@yahoo.com, dr.ghoba@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)