Brain Neoplasms
Conditions
Keywords
vitamin D, Brain Neoplasms, perioperative complications, clinical outcomes, craniotomy, Immune System
Brief summary
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.
Detailed description
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.
Interventions
DRUGvitamin D
Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
OTHERcontrol
No intervention
Sponsors
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D level | Postoperative day 5 | 25(OH) will be measured after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Complications | 30 days after surgery | Complications after hospital discharge |
| Duration of stay in ICU | 30 days | Length of stay in ICU is measured |
| Peri-operative Complications | During surgery, recovery and hospitalization (5 days post op) | Complications in operating room, recovery room, ICU and neurosurgery ward |
| 1-month mortality | 30 days | Mortality during hospitalization or 1 month after surgery |
| 6-month mortality | 6 months | Mortality during 6 months after surgery |
| Duration of stay in hospital | 30 days | Length of stay in hospital is measured |
Countries
Iran
Outcome results
None listed