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IRCT20200324046844N1 IRCT 2020-05-19 Shiraz University of Medical Sciences Ultra dose vitamin D supplementation in ventilator associated pneumonitis (VAP) patients Effects of ultra dose vitamin D supplementation on remission, morbidity and mortality of ventilator associated pneumonitis (VAP) patients: A Randomized Controlled Trial study. 2020-04-29 anticipated 42 Complete https://irct.ir/trial/46703 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method will be used to randomize every patient individually by usage of www.sealedenvelope.com cite. Then, the computer software will be used. The random sequence will be built by the software, Blinding description: In this RCT, the participants, investigator, healthcare providers (including the pulmunologist who visits the patient and the nurses who provide vitamin D or placebo to the patient), data analyser and the outcome assessor would not informed about the provided intervention to the patient (vitamin D or placebo). 3 Ventilator associated pneumonitis (VAP). Intervention 1: Intervention group: 2 cc/day vitamin D with the dose of 100000 units orally for five days from Zahravi drug company. Intervention 2: Control group: 2 cc/day olive oil as placebo for five days, orally. Yes - There is a plan to make this available What will be shared: Data about the outcomes are available When: 3 months after publication To whom: People who are working in academic institutions Conditions: Statistical analysis are available. Where to obtain: Asking from Dr. Zohreh Mazloom and Seyed Abolfazl Azariyan by sending Email to these adresses: zohres.mazloom@gmil.com and Abolfazlazariyan1@gmail.com How to obtain: Email may be answered after 1 months of sending Email. Comments:
public Seyed Abolfazl Azariyan
No. 19, Alley 48, Sayyad Shirazi Ave., Mashhad Town, Razavi Khorasan Province, Iran
Mashhad Iran (Islamic Republic of) 1547896485 +98 61 4255 8194 abolfazlazariyan1@gmail.com Shiraz University of Medical Sciences scientific Zohreh Mazloom
No 439 , Alley 82/9 ,Ghasrdasht Ave.
Siraz Iran (Islamic Republic of) 1547896520 +98 71 8745 6321 zohres.mazloom@gmil.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Pneumonia Severity Index (PSI) score above 51 The level of vitamin D below 20 ng/ml at the admission to the hospital Absence of hypercalcemia at the admission to the hospital (calcium concentration above 10.8 mg/dl) Stable hemodynamic status Not consuming hydrochlorothiazide, digoxin and magnesium containing antacids Absence of history of consuming vitamin D during the past four months with the dose above 1000 units Able to be be fed enterally at the 24 to 48 hours from the admission time Signing the consent form by the family of patients Absence of any of these disease: hyperparathyroidism, nephrolithiasis, sarcoidosis, chronic kidney disease, cirrhosis, metabolic diseases, acquired immune deficiency syndrome (AIDS), cardiovascular disease, diabetes mellitus, cancers and autoimmune diseases Not being pregnant Not involved in other research projects 18 years 65 years Both Presence of other types of pneumonitis Dying earlier than 7 days of intervention Presence of any condition leading to enteral feeding disruption during the first 5 days of intervention If the supplementation is thought to be hazardous or being forbidden by the general practitioner Treatment - Other Placebo Intervention group: 2 cc/day vitamin D with the dose of 100000 units orally for five days from Zahravi drug company Control group: 2 cc/day olive oil as placebo for five days, orally Morbidity and organ failure calculated by the Sequential Organ Failure Assessment (SOFA) score, mortality risk assessed by the Acute Physiology and Chronic Health Enquiry (APACHE-II) score and change in the Pneumonia Severity Index (PSI) score. Timepoint: Completing the questionnaires and telephone contact about death after releasing from hospital in the 28 days after intervention. Method of measurement: SOFA, APACHE-II and PSI questionnaire and mortality numbers by telephone for released patients. SOFA, APACHE-II and mortality rate. Timepoint: On day 0, 7 and 14 of the intervention. Method of measurement: On day 0, 7 and 14 of the beginning of the intervention we will complete the SOFA & APACHE-II questionnaire and on day 28 we will ask the family of the patients for death after releasing from hospital. Shiraz University of Medical Sciences Approved 2020-02-26 Human Research Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Opposite Palestine St., Zandani St. Shiraz Fars Iran (Islamic Republic of)