Vitamin D supplementation not only has beneficial effects on morbidity and mortality in critically ill patients but it may also lead to alleviate of seizure, brain edema, infection, pain and some other perioperative complications, possibly in part through an attenuation of the immune response.In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to control group.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Tehran, Iran
Shohada Tajrish Hospital
Tehran, Iran
Vitamin D level
25(OH) will be measured after surgery
Time frame: Postoperative day 5
Peri-operative Complications
Complications in operating room, recovery room, ICU and neurosurgery ward
Time frame: During surgery, recovery and hospitalization (5 days post op)
Post-operative Complications
Complications after hospital discharge
Time frame: 30 days after surgery
Duration of stay in ICU
Length of stay in ICU is measured
Time frame: 30 days
Duration of stay in hospital
Length of stay in hospital is measured
Time frame: 30 days
1-month mortality
Mortality during hospitalization or 1 month after surgery
Time frame: 30 days
6-month mortality
Mortality during 6 months after surgery
Time frame: 6 months
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