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IRCT20180619040151N3 IRCT 2019-08-10 Mashhad University of Medical Sciences Effect of vitamin D in severe traumatic brain injury Comparison of the efficacy of high and low doses vitamin D supplementation on serum levels of inflammatory factors and mortality in patients with severe head trauma. 2019-08-11 anticipated 70 Complete https://irct.ir/trial/35898 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: For randomization, the permuted block randomization method with blocks of size 4 is used. According to the sample size of 80, 20 blocks of size four will be produced using the online site (www.sealedenvelope.com), Blinding description: In order to apply blur in the randomization process, unique codes will be used on supplemental boxes, which will be generated by this software. By entering each individual into a study based on the sequence produced, the boxes of the drug that the code is registered on is assigned to the person and therefore, before the person is selected, one does not know the type of treatment he receives. Given that the box of vitamin D and placebo are named by the codes , the investigator, the patient, and the data analyzer are blinded. 3 Condition 1: Epidural hemorrhage. Condition 2: Traumatic subdural hemorrhage. Intervention 1: Intervention group: drop of vitamin D3, 100000 IU daily for 5 days, and 1000 IU daily from day 6 to day 14. Intervention 2: Control group: drop of vitamin d3 1000 IU, daily for 14 days. 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 Seyed Mostafa Arabi
Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7033 arabim941@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Mostafa Arabi
Azadi squer, Mashhad university of medical sciences
mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7033 arabim941@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having vitamin D levels below 20 nmol/g/ml at the time of admission in the ICU Glasgow coma scale (GCS) Between 7 and 9 Completion of informed consent form from patients' first-degree reletives Achieving hemodynamic stability (no arterial pressure lower than 60 mmHg for at least 3 hours, stopping development epidoral, subdural or interacranial hematoma) Entreal ability to feed in the first 24 to 48 hours of admission Receiving the standard dose of Dilantin according to the treatment protocol for patients with traumatic brain injury Age 18 to 65 years 18 years 65 years Both Receiving Corticosteroids Severe and active bleeding Receive hydrochlorothiazide, digoxin and magnesium-containing antioxidants History of treatment with a high dose of 1000 units of vitamin D in the last 4 months Sepsis and pneumonia at the beginning of the study Hyperparathyroidism, sarcoidosis, nephrolithiasis, chronic renal failure, cirrhosis and AIDS Presence of autoimmune disease Hypercalcemia at the beginning of the study (calcium-albumin more than 10.8) Cancer, diabetes, and cardiovascular disease Pregnancy S06.4 S06.5 Epidural hemorrhage Traumatic subdural hemorrhage Treatment - Drugs Placebo Intervention group: drop of vitamin D3, 100000 IU daily for 5 days, and 1000 IU daily from day 6 to day 14 Control group: drop of vitamin d3 1000 IU, daily for 14 days Interleukin-6. Timepoint: Measurement of Interleukin-6 at the beginning of the study and on days 7 and 14 after vitamin D supplementation. Method of measurement: Serum measurement with ELISA method. Monocyte Chemoattractant Protein-1 (MCP-1). Timepoint: Measurement of Monocyte Chemoattractant Protein-1 at the beginning of the study and on days 7 and 14 after vitamin D supplementation. Method of measurement: Serum measurement with ELISA method. C-reactive protein. Timepoint: Measurement of C-reactive protein at the beginning of the study and on days 7 and 14 after vitamin D supplementation. Method of measurement: Serum measurement with ELISA method. 28 days mortality. Timepoint: Measurement of mortality at the beginning of the study and day 28. Method of measurement: Death record. Delirium. Timepoint: Before intervention, day 7 and 14. Method of measurement: The Confusion Assessment Method for the ICU. Glasgow coma score. Timepoint: Before intervention, day 7 and 14. Method of measurement: Glasgow Coma Scale. Acute Physiology and Chronic Health Evaluation (APACHE II) score. Timepoint: Before intervention, day 7 and 14. Method of measurement: Acute Physiology and Chronic Health Evaluation (APACHE II) score. Sequential Organ Failure Assessment (SOFA) score. Timepoint: Before intervention, day 7 and 14. Method of measurement: Sequential Organ Failure Assessment (SOFA) Score. Mashhad University of Medical Sciences Approved 2018-10-06 Ethics committee of Mashhad University of Medical Sciences Azadi square Mashhad Razavi Khorasan Iran (Islamic Republic of)