Comparing the effect of different dose of vitamin D on vitamin D level in patients with severe chronic obstructive pulmonary disease based on GOLD criteria with vitamin D deficiency
Comparing the effect of different dose of vitamin D on level of vitamin D in patients with sever chronic obstructive pulmonary disease based on GOLD criteria and referred to Velayat hospital of Qazvin in year of 2018
Design
Clinical trial, with parallel groups, double-blind (patient and evaluator), randomized, phase 3 on 46 patients. To randomize, generate random numbers in the software.
Settings and conduct
Patients with severe chronic obstructive pulmonary disease who are referred to Velayat hospital of Qazvin, enter to the study after obtaining consent form. Spirometry test and their vitamin D levels are assessed according to the GOLD criteria. Then they are randomly divided into two groups with 23 cases. One group is treated with 4,000 units of vitamin D daily, and the other group is treated with 50,000 units of vitamin D a week for 12 weeks. Patient and evaluator are not aware of the type of treatment groups. Spirometry test and vitamin D levels are assessed again after 5 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient with sever chronic obstructive pulmonary disease, vitamin D deficiency (less than 30 nanogeram per milli liter). Exclusion criteria: History of advanced liver disease, history of advanced kidney disease, history of drug use (barbiturates, phenytoin and rifampin) during the last three months
Intervention groups
Treatment of vitamin D deficeincy with vitamin D 4000 unit daily for 12 week in intervention group and 50000 unit weekly for 12 week in control group
Main outcome variables
vitamin D level ; COPD severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180924041108N1
Registration date:2020-07-11, 1399/04/21
Registration timing:retrospective
Last update:2020-07-11, 1399/04/21
Update count:0
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Maryam Qeraati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 0620
Email address
m.gharati@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of different dose of vitamin D on vitamin D level in patients with severe chronic obstructive pulmonary disease based on GOLD criteria with vitamin D deficiency
Public title
The effect of different doses of vitamin D on vitamin D levels in patients with severe chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
sever chronic obstructive pulmonery disease
Vitamin D deficiency (less than 30 nanogram per milliliter)
Exclusion criteria:
History of advanced liver disease
history of advanced kidney disease
history of drug use (barbiturates, phenytoin and rifampin) during the last 3 months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method is done as individually and using software.
In the software, we generate random numbers between zero and one. For numbers less than 0.5, the person is placed in group A and for numbers greater than 0.5, the person is placed in group B.
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
Ethics committee of Qazvin University of Medical Sciences