Study of the effect of vitamine D3 on incidence of exacerbations and infections of ‘chronic obstructive pulmonary disease’ patients (COPD) with serum levels of vitamine D less than 75 nmol/L.
Objectives: 1. to define the effectiveness of supplementary vitamin D3 in lengthening time to COPD exacerbations. 2. to define the effect of supplementary vitamin D3 in lengthening of time to respiratory tract infection.
Design: a randomized double blind clinical trial; the intervention group will receive vitamine D 50000 IU on a weekly baisis on saturdays after lunch and the placebo group will receive placebo on the same time schedule. The study is double blind, i.e. neither patients nor their physicians will know in which group the patients are. The primary outcome is the number of exacerbations, in addition time to exacerbation will be another evaluation variable.
Inclusion criteria: All COPD patients including those with emphysema and chronic bronchitis with serum vitamin D-25 level less than 75 nmol/L.
Exclusion criterial: 1. patients younger than 40 yrs; 2. patients with FEV1/FVC < 70%; 3. patients that after inhalation of 400 microgra salbutamol have FEV1/FVC > 70%; 4. patients with history of consumtion of less than 15 pack year cigarettes; 5. patient with asthma or history of asthma; 6. patients with serum level of vitamine D > 75 mnol/L.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022826816N1
Registration date:2016-05-05, 1395/02/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Shirin Izadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7742 8021
Email address
izadi.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-06-20, 1395/03/31
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of vitamine D3 on incidence of exacerbations and infections of ‘chronic obstructive pulmonary disease’ patients (COPD) with serum levels of vitamine D less than 75 nmol/L.
Public title
Prevention of COPD exacerbation by normalizing serum vitamin D3 level.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterial: All COPD patients including those with emphysema and chronic bronchitis with serum vitamin D-25 level less than 75 nmol/L.
Exclusion criterial: 1. patients younger than 40 yrs; 2. patients with FEV1/FVC < 70%; 3. patients that after inhalation of 400 microgra salbutamol have FEV1/FVC > 70%; 4. patients with history of consumtion of less than 15 pack year cigarettes; 5. patient with asthma or history of asthma; 6. patients with serum level of vitamine D > 75 mnol/L; 7. patients with diabetes, renal failure, history of MI, bronchiectasia, sarcoidosis, hypoparathyroidism, nephrolithiasis, active TB, liver failure, malignancy with remission less than 3 years age; 8. patients under treatment with carbamazepine, cardiac glycosides, phenobarbital, phenytoin, perimidon; 9. patients with serum calcium level above 2.65 mmol/L or serum creatinine level above 125 micromol/L; 10. patients unable to cooperate with spirometery; 11. patient who need to receive more than 12 hrs per day oxygen.
Age
From 40 years old to 80 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Medical Research of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences
City
Tehran
Postal code
Approval date
2016-02-13, 1394/11/24
Ethics committee reference number
IR.IUMS.REC.1394.27529
Health conditions studied
1
Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Primary outcomes
1
Description
occurance of an exacerbation of COPD
Timepoint
Monthly
Method of measurement
clinical and paraclinical observations
Secondary outcomes
1
Description
functional class of the patients
Timepoint
End of the study
Method of measurement
clinical observation and interview
Intervention groups
1
Description
Intervention: administration of Vitamin D3,
Control: Placebo
Category
Treatment - Drugs
2
Description
The control group (Placebo): This group will receive a placebo capsule after lunch on Saturday, each week for 12 consecutive weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar General Hospital
Full name of responsible person
Shirin Izadi
Street address
Firoozgar General Hospital; Valiasr Ave.; Tehran; I.R.Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shirin Izadi
Street address
Firoozgar General Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shirin Izadi
Position
MD
Other areas of specialty/work
Street address
Firoozgar General Hospital
City
Tehran
Postal code
Phone
+98 21 7742 8021
Fax
Email
izadi.sh@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shirin Izadi
Position
Atending Professor
Other areas of specialty/work
Street address
Firoozgar General Hospital
City
Tehran
Postal code
Phone
+98 21 7742 8021
Fax
Email
izadi.sh@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shirin Izadi
Position
Attending Professor
Other areas of specialty/work
Street address
Firoozgar General Hospital
City
Tehran
Postal code
Phone
+98 21 7742 8021
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)