Inclusion criteria; All eligible patients with chronic obstructive pulmonary diseases(COPD) will be included to study . Exclusion criteria; Patients with chronic pulmonary infections ,restrictive airway diseases,cor pulmonale,congestive heart failure,pulmonary emboli neoplasia,occupational lung disease and pregnant women will be excluded
Intervention; Patients will take 50.000 IU oral vitamin D3 weekly in addition to their usual treatment regimen.Controls group take in addition to the usual drug and in the remaining 30 patients placebo will be added to their usual drugs
Primary outcome; Mean differences in FEV1,FVC,FEV1/FVC,from baseline after 3 and six months
Secondary outcome;Proportions of patients responded to the treatment (defined as 20% improvement in FEV1 absolute value in ml compared with baseline values) in treatment group compared with placebo group
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103154724N2
Registration date:2011-07-24, 1390/05/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-24, 1390/05/02
Registrant information
Name
Mahmood Monadi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8284
Email address
drmonadi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research ,Babol university of medical sciences
Expected recruitment start date
2011-06-21, 1390/03/31
Expected recruitment end date
2011-12-23, 1390/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of vitamin D in the improvement of pulmonary function tests in patients with chronic obstructive pulmonary disease
Public title
Vitamin D and airway obstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : All eligible patients with chronic obstructive pulmonary diseases(COPD) will be included to study. Exclusion criteria :Patients with chronic pulmonary infections ;restrictive airway diseases;cor pulmonale;congestive heart failure;pulmonary emboli neoplasia;occupational lung disease and pregnant women will be excluded .
Age
From 35 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comittee Babol university of medical science
Street address
Rohani hospital, Keshavarz Blvd, University Sq
City
Babol
Postal code
4717641367
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
8928513
Health conditions studied
1
Description of health condition studied
COPD patients
ICD-10 code
J40
ICD-10 code description
Bronchitis, not specified as acute or chronic
2
Description of health condition studied
COPD
ICD-10 code
J41
ICD-10 code description
Simple and mucopurulent chronic bronchitis
3
Description of health condition studied
COPD
ICD-10 code
J42
ICD-10 code description
Unspecified chronic bronchitis
4
Description of health condition studied
COPD
ICD-10 code
J43
ICD-10 code description
Emphysema
5
Description of health condition studied
COPD
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
6
Description of health condition studied
COPD
ICD-10 code
J45
ICD-10 code description
Asthma
7
Description of health condition studied
COPD
ICD-10 code
J46
ICD-10 code description
Status asthmaticus
8
Description of health condition studied
COPD
ICD-10 code
J47
ICD-10 code description
Bronchiectasis
Primary outcomes
1
Description
Mean differences in FEV1,FVC,FEV1/FVC,from baseline after 3 and six months
Timepoint
3 months and 6 months interval
Method of measurement
Pulmonary function test (PFT)
Secondary outcomes
1
Description
Proportions of patients responded to the treatment (defined as 20% improvement in FEV1 absolute value in ml compared with baseline values) in treatment group compared with placebo group
Timepoint
After 3 months and 6 months of treatment
Method of measurement
PFT
Intervention groups
1
Description
30 patients will take 50.000 IU oral vitamin D3 weekly in addition to their usual treatment regimen of vitamin D will be adjusted over the study period to maintain serum 25-hydroxyvitamin D levels at 30-70 ng/ml by extending the dosage interval from one to 4 weeks .
Category
Treatment - Drugs
2
Description
The control group receives placebo in addition to their usual drugs