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IRCT20120703010178N23 IRCT 2021-01-16 Shahid Beheshti University of Medical Sciences The effect of vitamin D3 supplementation on AKI risk in multiple trauma patients admitted to ICU with elevated CPK level The effect of vitamin D3 supplementation on AKI risk in multiple trauma patients admitted to ICU with elevated CPK level 2020-01-21 anticipated 30 Complete https://irct.ir/trial/52580 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization was done by block randomization method using a randomization table made with statistical software with four blocks and individual randomization unit. To hide this table, there is only one copy of this table without specifying the study groups that are maintained by the study host in the center. N/A Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. Intervention 1: Control group : patients with serum CPK level higher than 1000 I.U, no intervention, just observational. Intervention 2: Intervention group: : patients with serum CPK level>1000 I.U, received a only a single dose of 300.000 I.U vitamin D3 intramuscular (IM) (darupakhsh company). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8820 0087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8820 0087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) patients over 18 patients with at least two distinct injuries who were diagnosed with multiple trauma Serum creatinine phosphate level higher than or equal to 5 times normal, from admission to the intensive care unit up to 48 hours later 18 years no limit Both Patients with a recent history of myocardial infarction (within one week before the trauma) pregnancy or lactation, patients with direct kidney trauma high serum vitamin D3 levels patients who received more than 2000I.U of vitamin D3 per day during the past week, total calcium level above 9 mg/dl or phosphate level above 6 mg/dl at the time of admission, history of organ transplantation or long-term use of immunosuppressive drugs, patients with a history of diseases related to vitamin D3 levels, such as primary parathyroid, metabolic bone disease, or acute renal failure N.17.9 Acute kidney injury Other Prevention Control group : patients with serum CPK level higher than 1000 I.U, no intervention, just observational. Intervention group: : patients with serum CPK level>1000 I.U, received a only a single dose of 300.000 I.U vitamin D3 intramuscular (IM) (darupakhsh company) Prevalence of acute kidney injurie. Timepoint: within 2 weeks if ICU admission. Method of measurement: laboratory results of Serum creatinine; urine output. Serum creatine phosphokinase level. Timepoint: Daily from the ICU admission date up to either reaching normal level or 14 days. Method of measurement: Serum CPK level laboratory measurement kits. Follow up death for 28 days. Timepoint: since admitted it the ICU we follow up daily up to 28 days. Method of measurement: dead or alive before the 28 days follow up. Shahid Beheshti University of Medical Sciences Approved 2018-07-02 Ethics Committee of Shahid Beheshti University Shahid Beheshti University of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)