The main objective of this randomized clinical trial is to evaluate the effect of vitamin D on chronic obstructive lung diseases. Eighty patients with stable COPD who are suffering from concurrent vitamin D deficiency will be selected from those who are attending the outpatient clinic at Marvdasht hospital in 1395. Patients will be excluded if they have a history of TB, asthma, active cancer, diabetes, and any disease that affect vitamin D level.
Forty patients will be randomly assigned to the intervention group (using a random permutation of numbers table) and will receive 50000 IU vitamin D, weekly for 10 weeks and the other group (control) will receive placebo weekly for 10 weeks (single-blinded).
The outcome parameter will be FEV1 after 3 months. Both groups with all 4 stages of severity will be reassessed by FEV1 to show response to therapy. FEV1 above 80% will be marked as mild COPD, 50 to 79% will be moderate COPD, 30 to 49% as severe, and less than 30% as very severe COPD. All stages of COPD disease will be compared in intervention and control groups before and after vitamin D deficiency treatment. An improvement in the stage of severity of COPD will be considered as a significant improvement.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610306312N3
Registration date:2017-04-01, 1396/01/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-01, 1396/01/12
Registrant information
Name
Amir Anushiravani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1634 4292
Email address
anushirvan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-11-01, 1395/08/11
Expected recruitment end date
2017-01-31, 1395/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial to compare the effect of vitamin D and placebo on FEV1 in patients with chronic obstructive pulmonary disease
Public title
The effect of vitamin D on chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Eighty cases of stable COPD with vitamin D deficiency.
Exclusion criteria: past history of TB; asthma; active cancer; diabetes; hypertension; ischemic heart disease; chronic kidney disease; liver failure; history of upper or lower respiratory tract infections; use of oral steroid within 1 month prior to study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients will be randomly allocated in case and groups using a permutation of 20numbers table. 0-4 will be placed in the case group and 5-9 in the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences