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IRCT2014112920134N1 IRCT 2015-01-31 Chancellor for research, shahid beheshti medical university Evaluation of vitamin D supplementation on outcome of patients with ventilator associated pneumonia Study of the effect of vitamin D supplementation on outcome and prognostic biomarkers of VAP in patient with vitamin D deficiency 2014-09-23 anticipated 46 Complete https://irct.ir/trial/17865 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Condition 1: ventilator associated pneumonia. Condition 2: ventilator associated pneumonia. Condition 3: ventilator associated pneumonia. Condition 4: ventilator associated pneumonia. Condition 5: ventilator associated pneumonia. Condition 6: ventilator associated pneumonia. Intervention 1: Intramuscular injection of 300,000 IU of vitamin D in the treatment group as a single dose on the first day of treatment only. Intervention 2: Intramuscular injection of vitamin D placebo in the control group as a single dose on the first day of study.
public "Salamzadeh Jamshi"
"Vali Asr Avenue, below the Niayesh highway, Tehran, Zip Code: 1991953381"
Tehran Iran (Islamic Republic of) +98 21 8887 3704 j.salamzadeh@yahoo.com Shahid Beheshti University of Medical Sciences, School of Pharmacy scientific "Sahraee Zahra"
"Vali Asr Avenue, below the Niayesh highway, Tehran, Zip Code: 1991953381"
Tehran Iran (Islamic Republic of) +98 21 8887 3704 zahra.sahraee@yahoo.com Shahid Beheshti University of Medical Sciences, School of Pharmacy Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Patients over 18 years old, that clinically and based on the following criteria have been diagnosed with VAP (During the first 48 hours of diagnosis): The presence of new or progressive infiltration on the patient's chest radiograph that occur 48-72 hours after initiation of mechanical ventilation, While two of the following symptoms must be present with it: Fever over 38 ° C; leukocytosis or leukopenia (white blood cell count greater than 12,000 per µL of blood or less than 4000 per µL blood) and purulent pulmonary secretions. Exclusion criteria: Stage3 or more chronic kidney problems; liver problems with CHILD-PUGH stage B or C; history of cancer within the last 3 months, or currently taking chemotherapy drugs; patients with immune deficiency; pancreatitis; other infections, concurrently with pneumonia caused by mechanical ventilation, patients with VAP that the vitamin D levels are normal and Coagulopathy. 17 years no limit Both J13 J16 J14 J15 J17 J18 Pneumonia due to Streptococcus pneumoniae Pneumonia due to other infectious organisms, not elsewhere classified Pneumonia due to Haemophilus influenzae Bacterial pneumonia, not elsewhere classified Pneumonia in diseases classified elsewhere Pneumonia, organism unspecified Treatment - Drugs Treatment - Drugs Intramuscular injection of 300,000 IU of vitamin D in the treatment group as a single dose on the first day of treatment only Intramuscular injection of vitamin D placebo in the control group as a single dose on the first day of study Procalcitonin plasma level. Timepoint: Day 1 and 7 of study. Method of measurement: Plasma level that measured with electrochemiluminescence and reported as ng/ml. C-reactive protein plasma level. Timepoint: Day 1 and 7 of study. Method of measurement: Plasma level that measured with elisa kit and reported as mg/L. Interleukin-6 plasma level. Timepoint: Day 1 and 7 of study. Method of measurement: Plasma level that measured with elisa kit and reported as pg/ml. Vitamin D plasma level. Timepoint: Day 1 and 7 of study. Method of measurement: Plasma level that measured with elisa kit and reported as ng/ml. Outcom at 28 days. Timepoint: Day 28. Method of measurement: Evaluation of mortality. Chancellor for research, shahid beheshti medical university Approved 2014-09-10 Ethics Committee Shahid Beheshti University of Medical Sciences, School of Pharmacy "Vali Asr Avenue, below the Niayesh highway, Tehran, Zip Code: 1991953381" Tehran Iran (Islamic Republic of)