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

July 29, 2018 updated by: Zahra Vahdat Shariatpanahi, Shahid Beheshti University

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tehran, Iran, Islamic Republic of
        • Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
      • Tehran, Iran, Islamic Republic of
        • Shohada Tajrish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vitamin D
Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection
Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
Other Names:
  • Cholecalciferol
OTHER: control
Control patients will not be received any intervention
No intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Zahra Vahdat Shariatpanahi, MD, PhD, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2017

Primary Completion (ACTUAL)

July 30, 2018

Study Completion (ACTUAL)

July 30, 2018

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (ACTUAL)

August 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 29, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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