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

Not Applicable

Completed

• Conditions: Brain Neoplasms
• Interventions: Other: control; Drug: vitamin D

• Registration Number: NCT03248544
• Lead Sponsor: Shahid Beheshti University

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.

Study Timeline

• Study Start: 2017-07-06
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-14
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-29
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	Control patients will not be received any intervention
vitamin D	vitamin D	Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection

Primary Outcome Measures

Name	Time	Method
Vitamin D level	Postoperative day 5	25(OH) will be measured after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Shohada Tajrish Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of