Effect of Single High Dose Vitamin D3 on Peri-operative and Post-operative Complications and Clinical Outcomes in Patients Under Craniotomy for Brain Tumor Resection
vitamin D
+ control
Brain Diseases+5
+ Brain Neoplasms
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: July 6, 2017
Actual date on which the first participant was enrolled.A randomized, double blind, controlled trial will be conducted in neurosurgery ward, operating room (OR) and intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 60 eligible hospitalized patients that diagnosed with brain tumor and need to craniotomy, aged ≥ 18 years. Intervention patients will be received an intramuscular (IM) single dose of vitamin D (300000 IU). Patients will be evaluated for occurrence of perioperative complications and clinical outcomes immediately after surgery until 1 month later and 1 and 6 months mortality.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Written informed consent of patient or legal representative * 25(OH)D level below 20ng/dL Exclusion Criteria: * Other trial participation, including previous participation in the pilot trial * Pregnant or lactating women * Hypercalcemia * Hyperphosphatemia * Tuberculosis * Sarcoidosis * History of nephrolithiasis * History of hyperparathyroidis * Medications that interfere with vitamin D metabolism * Renal Insufficiency
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic ofSee the locationShohada Tajrish Hospital
Tehran, Iran, Islamic Republic of