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IRCT2016031425726N4 IRCT 2016-05-15 Research council of School of Pharmacy, Shahid Beheshti University Effecct in recovery of inflamation and respiratory function in chronic obstructive pulmonary disease. Effects of high dose vitamin D‏ ‏as adjunctive therapy on ‎clinical outcomes and prognostic biomarkers in patients with Acute ‎Exacerbation of Chronic Obstructive ‎‏ ‏Pulmonary Disease. ‎ 2016-04-17 anticipated 70 Complete https://irct.ir/trial/21470 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A acute ecxacerbation of chronic obstroctive lung disease. Intervention 1: control group recieves standard therapy. Intervention 2: Intervention group recieve vitamin D 300,000 IU intramuscullaryin addition to standard therapy of AECOPD.
public dr Seyed mouhmad hassn pourrashid
Niayesh Highway, Valiasr Ave, Tehran, Iran
tehran Iran (Islamic Republic of) 6153- 14155 +98 2188200118120 smhpz@yahoo.com faculty of pharmacy Shahid Beheshti University of Medical Sciences scientific Dr Farzaneh dastan
Niayesh Highway, Valiasr Ave, Tehran, Iran
tehran Iran (Islamic Republic of) 6153- 14155 +98 2188200118120 f_dastan@sbmu.ac.irfzh.dastan@gmail.com Faculty of pharmacy Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria include; Vitamin D deficiency (serum 25(OH)D < 50 nmol/l) ‎ Postbronchodilator FEV1/FVC < 0.70, FEV1< 80 % and diagnosis acute exacerbation of COPD confirmed by a physician Age≥40 years ‎ Written informed consent ‎ Ability to comply with all study requirements Exclusion criteria include Severe vitamin D deficiency (serum 25(OH)D <15 nmol/l),‎ Use of a supplement containing more than 400 IU vitamin D per day Diagnosed asthma Diagnosed osteoporosis Self-reported history of hypercalcaemia or nephrolithiasis Self-reported presence of sarcoidosis Diagnosed chronic kidney disease stage 4 or higher (eGFR≤29 ml/min/1.73 m2)‎ liver insufficiency child pough class B or C Interfering malignant diseases Life expectation of less than 1 year on the basis of concurrent disease Current participation in a clinical rehabilitation program Pregnant or lactating women, or subjects who intend to become pregnant within the study period Potentially unreliable patients and those judged by the investigator to be unsuitable for the study Serious mental impairment i.e. preventing to understand the study protocol or comply with the study aim. 40 years 139 years Both J44.1 Chronic obstructive pulmonary disease with acute exacerbation, unspecified N/A Treatment - Drugs control group recieves standard therapy Intervention group recieve vitamin D 300,000 IU intramuscullaryin addition to standard therapy of AECOPD Interleukin 6 and interleukin 8 and hsCRP LEVEL. Timepoint: day of admision and day 5. Method of measurement: ELISA. Modified medical research council dyspnea scale. Timepoint: day of admision-day 5 and mounth 3 after inclusion to study. Method of measurement: questionaire. St george respiratory questionnaire quality of life. Timepoint: day 1 and 90 after admission. Method of measurement: Patient-reported Outcomes & questionnaire fill out. Research council of School of Pharmacy, Shahid Beheshti University Approved 2016-03-01 pharmacy and nursing and midwifery faculti,s Ethics committee Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Iran (Islamic Republic of)