Objectives: To assess the effect of vitamin D supplementation on moderate to severe asthma.
Design: A triple blinded randomized clinical trial.
Setting and conduct: All eligible patients with moderate to severe asthma who will refer to clinic of Shahid Beheshti Hospital will be enrolled in to the trial.
Inclusion criteria: (a) having moderate to severe asthma; (b) age of 18 or above; (c) documented vitamin D deficiency (vitamin D level less than 20 ngr/ml).
Exclusion criteria: (a) being pregnant; (b) using calcium or vitamin D during the last 3 months; (c) having history of mal-absorption or using drugs effecting vitamin D absorption and metabolism; (d) having other chronic obstructive lung diseases or thoracic skeletal defect.
Intervention: Routine treatment of asthma plus oral vitamin D 50000 IU single dose, every week, for eight weeks
Control: Routine treatment of asthma
Primary outcome: (a) measuring forced expiratory volume in the first second (FEV1) per liter at baseline and eight weeks after treatment using spirometer; (b) measuring forced vital capacity (FVC) at baseline and eight weeks after treatment using spirometer.
Secondary outcome: nausea and vomiting
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402029014N22
Registration date:2014-05-26, 1393/03/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-26, 1393/03/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation versus placebo on moderate to severe asthma: A triple blinded randomized clinical trial
Public title
The effect of vitamin D supplementation versus placebo on moderate to severe asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) having moderate to severe asthma; (b) age of 18 or above; (c) documented vitamin D deficiency (vitamin D level less than 20 ngr/ml).
Exclusion criteria: (a) being pregnant; (b) using calcium or vitamin D during the last 3 months; (c) having history of malabsorption or using drugs effecting vitamin D absorption and metabolism; (d) having other chronic obstructive lung diseases or thoracic skeletal defect.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
P/16/35/9/701
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
measuring forced expiratory volume in the first second (FEV1)
Timepoint
at baseline and eight weeks after treatment
Method of measurement
using spirometer
2
Description
measuring forced vital capacity (FVC)
Timepoint
at baseline and eight weeks after treatment
Method of measurement
using spirometer
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
8 weeks after treatment
Method of measurement
Question
Intervention groups
1
Description
Routine treatment of asthma plus oral vitamin D 50000 IU single dose, every week, for eight weeks
Category
Treatment - Drugs
2
Description
Routine treatment of asthma
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Sadegh Dehghan
Street address
Shahid Beheshti Hospital, Eram Bul.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Shahid Beheshti Hospital
Full name of responsible person
Dr Mayam Vasheghani
Position
Specialist in Internal Medicine
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Bul.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0717
Fax
Email
mvasheghani9@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Mayam Vasheghani
Position
Specialist in Internal Medicine
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Bul.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0717
Fax
Email
mvasheghani9@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)