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IRCT138712271774N1 IRCT 2011-04-10 Vice chancellor for research, Kerman University of Medical Sciences PhYsiology resaerch center of Vitamin D and COPD 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. 2009-02-20 anticipated 120 Complete https://irct.ir/trial/1346 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Chronic obstructive pulmonary disease, unspecified. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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.
public ِDr. Mojgan Sanjari
Afzalipour Hospital, Kerman
Kerman Iran (Islamic Republic of) +98 341322225070 msanjari@kmu.ac.ir Kerman university of Medical sciences scientific Dr. Mojgan Sanjari
Afzalipour Hospital
Kerman Iran (Islamic Republic of) 7616913911 +98 341322225070 msanjari@kmu.ac.ir Kerman university of Medical sciences Iran (Islamic Republic of) 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. 40 years 60 years Both J44.9 Chronic obstructive pulmonary disease, unspecified Placebo Treatment - Drugs Treatment - Drugs 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. 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. 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. 25(OH)2vit D3. Timepoint: first and 8th day. Method of measurement: Enzyme assay. 1,25(oh)2vitD3. Timepoint: first and 8th day. Method of measurement: Enzyme assay. FEV1 and FVC. Timepoint: 8th day. Method of measurement: spirometry. C Reactive Protein,CRP. Timepoint: first and 8th day. Method of measurement: latex-enhanced immunoturbidimetric assay. Serum Total Antioxidant. Timepoint: first and 8th day. Method of measurement: Calorimetry. Vice chancellor for research, Kerman University of Medical Sciences PhYsiology resaerch center of Approved 2009-06-18 ٍEthics committee of kerman university of medical sciences jomhoori BLVD,central office of kerman university of medical sciences kerman Iran (Islamic Republic of)