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IRCT20120703010178N24 IRCT 2021-04-09 Shahid Beheshti University of Medical Sciences Effect of high dose vitamin D in patients with ischemic stroke Effect of high dose vitamin D on serum Neuron Specific Enolase (NSE) level as a marker of neuronal damage in patients with ischemic stroke 2020-04-20 anticipated 40 Complete https://irct.ir/trial/42729 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to intervention and control arms of the study by simple randomization method using a series of unique random numbers generated by the RAND function in Excel software as below: 1- In column A, numbers 1-30 and 31 to 60 categorized as control and intervention, respectively. 2- In column B, the RAND function was run. 3- Columns A and B were copied and the values pasted in another sheet. 4- The sheet was sorted based on column B. So, the subjects in column A (control and intervention) were distributed randomly based on the random numbers generated in column B. 5- Numbers 1 to 60 were allocated in column C as subject number. Column B was deleted. 2-3 ischemic stroke. Intervention 1: Intervention group: Patients receiving 600000 international unit of intramuscular vitamin D in day 0. Intervention 2: Control group: Patients receiving standard treatment. 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 Omid Hesami
Tehran, Shahid Madani Alley, below Shahid Madani Metro, Imam Hossein Medical, Educational, Research and Treatment Center.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 0087 hesami.omid@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mohammad Sistanizad
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with Ischemic Stroke Patients over 16 16 years 75 years Both Myocardial infarction in past 30 days Vitamin D level more than 30ng/ml 163.9 ischemic stroke Treatment - Drugs Other Intervention group: Patients receiving 600000 international unit of intramuscular vitamin D in day 0 Control group: Patients receiving standard treatment Changes in the neuron-specific enolase between two arms of the study. Timepoint: Before intervention and 3 days after intervention. Method of measurement: EIA kit for the measurement of neuron-specific enolase. National Institutes of Health Stroke Scale. Timepoint: Daily until hospital discharge. Method of measurement: National Institutes of Health Stroke Scale questioner. Barthel index. Timepoint: 3 months after stroke. Method of measurement: Barthel index questioner. Shahid Beheshti University of Medical Sciences Approved 2020-09-20 Ethics committee of Shahid Beheshti University of Medical Sciences Velenjak Street, Shahid Chamran High Way Tehran Tehran Iran (Islamic Republic of)