Clinical trial for comparing the effect of 25(oh)2vitD, calcitriol and placebo on pulmonary function test, serum C reactive protein and total antioxidant in patient with chronic obstructive pulmonary disease.
Chronic obstructive pulmonary disease (COPD) is a heterogeneous, multi-component disease which is a leading public health concern worldwide.Patients with COPD are prone to exacerbation that are an important determinant of health-related quality of life, morbidity and mortality . Few studies have reported on 25-OHD serum levels in COPD patients. Lower vitamin D status in African Americans correlates with an increased susceptibility to COPD . We designed a double blind randomized controlled trial to assess the role of exogenous supplementation of vitamin D and calcitriol or placebo on lung function , CRP level and systemic oxidant antioxidant levels, in the patients with COPD. In this study 120 patient with COPD exacerbation randomly divides to 3 groups .All patients should have no other significant disease .Patients receives 50000 unit 25(oh)2vitD or 25 µg calcitriol or seasame oil as placebo for 7 days and at first and 8th day pulmonary function test and serum Creative protein and total anti oxidant will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138712271774N1
Registration date:2011-04-10, 1390/01/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-10, 1390/01/21
Registrant information
Name
Mojgan Sanjari
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2506
Email address
msanjari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences, Physiology Research center of Kerman university of medical sciences and Endocrine research center of Tehran university of medical sciences
Expected recruitment start date
2009-02-20, 1387/12/02
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial for comparing the effect of 25(oh)2vitD, calcitriol and placebo on pulmonary function test, serum C reactive protein and total antioxidant in patient with chronic obstructive pulmonary disease.
Public title
Vitamin D and COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: 1.Having COPD exacerbation 2.Age between 40 and 60 years 3.Moderate to severe disease. Exclusion criteria 1.Unwillingness to participate in the study, 2.Unable to perform spirometry, 3.History of any other respiratory disorder including asthma , bronchial carcinoma,lower respiratory tract infection 4. Recent (within 4 wk) hospitalization for COPD, 6.Any medical condition which needed more invasive respiratory support,6.Evidence of hypercalcemia, renal failure, hyperparathyroidism, malignancy, history of renal stone, cardiac arrhythmia, or patients who were using lithium.
Age
From 40 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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 of kerman university of medical sciences
Street address
jomhoori BLVD,central office of kerman university of medical sciences
Group A(Placebo): Patients receives standard treatment for COPD as recommended by the GOLD guidelines plus placebo capsule (sesame oil), similar in appearance to active drug in group B and C, one capsule daily for a week.
Category
Placebo
2
Description
Group B: Patients receives standard treatment for COPD as recommended by the GOLD guidelines plus vitamin D ,25 (OH)-D3 (Pourateb, Iran) 50000 IU, one capsule daily for a week.
Category
Treatment - Drugs
3
Description
Group C: Patients receives standard treatment for COPD as recommended by the GOLD guidelines plus Calcitriol, 1, 25 (OH)2-D3 (Pourateb, Iran) 0.25 µg, one capsule daily for a week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital ,kerman Iran
Full name of responsible person
Dr. Maryam Zareinejad
Street address
pulmonary ward and internal medicine emergency room-afzalipour hospital-Kerman-Iran
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences PhYsiology resaerch center of
Full name of responsible person
Dr.Hamid Najafi pour,
Street address
Physiology research center, Ebne sina Ave, Jahad Blvd, Kerman, Iran
City
Kerman
Grant name
Grant code / Reference number
88/58
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman University of Medical Sciences PhYsiology resaerch center of