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IRCT2016053028176N1 IRCT 2016-06-23 Vice chancellor for research, Mashhad University of Medical Sciences Effect of zinc supplementation on severe head trauma patients Comparison of zinc supplementation and plasebo on clinical improvement of severe head trauma patients admitted to ICU: A Randomized Clinical Trial 2012-08-22 anticipated 100 Complete https://irct.ir/trial/22911 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: method of randomly allocation of the study is using random number tables. 2 severe head trauma. Intervention 1: Intervention: 120 mg zinc elemental (528 mg zinc sulfat) as 20 ml zinc solution that were prepared by the study pharmacist in the Investigative Pharmacy Research Centre affiliated to Mashhad University of Medical Sciences Number of use: 2 times per day (10 ml at any time) for 15 days. Intervention 2: Control: 20 ml distilled water that were prepared by the study pharmacist in the Investigative Pharmacy Research Centre affiliated to Mashhad University of Medical Sciences Number of use: 2 times per day (10 ml at any time) for 15 days.
public Mohamad safarian
Pardis ّAlley, Azadi Square
Mashhad Iran (Islamic Republic of) 917794-8564 +98 51 3882 8888 safarianM@mums.ac.ir Faculty of Medicine, Mashhad University of Medical Sciences scientific Maryam khazdouz
Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 45 3325 0610 maryam.khazdouz@hotmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Severe head trauma patients; aged between 18 to 65 years; GCS between 6-8 Exclusion criteria: patients undergoing a craniotomy; or with a medical history of liver, respiratory or renal disease; diabetes; hypertension and cardiovascular diseases; blood clotting problems; cancer and ongoing pregnancy; patients whit contraindication of enteral nutrition 18 years 65 years Both (S00-S09) Injuries to the head Treatment - Drugs Treatment - Drugs Intervention: 120 mg zinc elemental (528 mg zinc sulfat) as 20 ml zinc solution that were prepared by the study pharmacist in the Investigative Pharmacy Research Centre affiliated to Mashhad University of Medical Sciences Number of use: 2 times per day (10 ml at any time) for 15 days Control: 20 ml distilled water that were prepared by the study pharmacist in the Investigative Pharmacy Research Centre affiliated to Mashhad University of Medical Sciences Number of use: 2 times per day (10 ml at any time) for 15 days Glasgow outcome score (GCS). Timepoint: First 24 hours of admission, 7th, 16th and 28th day. Method of measurement: GCS table. Sequential Organ Failure Assessment (SOFA). Timepoint: First 24 h of admission, 7th and 16 th day. Method of measurement: SOFA table. Zinc plasma concentrations. Timepoint: First 24 hours of admission, 7th and 16th day. Method of measurement: Atomic absorption spectrophotometer. C-reactive protein (CRP). Timepoint: First 24 hours of admission and 16th day. Method of measurement: CRP ELISA Kit. Copper plasma concentrations. Timepoint: first 24 hours of admission, 7th and 16th day. Method of measurement: Atomic absorption spectrophotometer. Length of hospital stay (LOS). Timepoint: at discharge day. Method of measurement: number of hospitalization days. Glasgow Outcome Score (GOS). Timepoint: At hospital discharge day. Method of measurement: GOS table. Erythrocyte sedimentation rate (ESR). Timepoint: First 24 hours of admission and 16th day. Method of measurement: Centrifuged. White blood cell (WBC) count. Timepoint: First 24 hours of admission and 16th day. Method of measurement: Conunt of WBC with cell counter. Mortality rate. Timepoint: At hospital discharge day. Method of measurement: Conunt of patients (dead and alive). Enteral intake and parenteral administered. Timepoint: Daily. Method of measurement: Recods of amounts of intake. Vice chancellor for research, Mashhad University of Medical Sciences Approved 2012-07-22 Ethics committee of Mashhad University of Medical Sciences Administration Center(Qoreishi Building) – Daneshgah St Mashhad Iran (Islamic Republic of)