Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Brain Neoplasms

Intervention / Treatment
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* Drug: vitamin D
* Other: control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D<br>Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection | Drug: vitamin D<br>* Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection<br>* Other names: Cholecalciferol;|
| Other: control<br>Control patients will not be received any intervention | Other: control<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D level | 25(OH) will be measured after surgery | Postoperative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-operative Complications | Complications in operating room, recovery room, ICU and neurosurgery ward | During surgery, recovery and hospitalization (5 days post op) | 
| Post-operative Complications | Complications after hospital discharge | 30 days after surgery | 
| Duration of stay in ICU | Length of stay in ICU is measured | 30 days | 
| Duration of stay in hospital | Length of stay in hospital is measured | 30 days | 
| 1-month mortality | Mortality during hospitalization or 1 month after surgery | 30 days | 
| 6-month mortality | Mortality during 6 months after surgery | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical outcomes, vitamin D, Brain Neoplasms, perioperative complications, craniotomy, Immune System