Completed

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

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What is being tested

vitamin D

+ control
Drug
Other
Who is being recruted

Brain Neoplasms

Over 18 Years
+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: July 2017

See protocol details

Summary

Principal SponsorShahid Beheshti University
Last updated: July 31, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: July 6, 2017Actual date on which the first participant was enrolled.

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.

Official TitleEffect of Single High Dose Vitamin D3 on Peri-operative and Post-operative Complications and Clinical Outcomes in Patients Under Craniotomy for Brain Tumor Resection 
Principal SponsorShahid Beheshti University
Last updated: July 31, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
60 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Brain Neoplasms
Criteria
2 inclusion criteria required to participate
Written informed consent of patient or legal representative
25(OH)D level below 20ng/dL
10 exclusion criteria prevent from participating
Other trial participation, including previous participation in the pilot trial
Pregnant or lactating women
Hypercalcemia
Hyperphosphatemia

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection
Group II
Control patients will not be received any intervention
Study Objectives
Primary Objectives

25(OH) will be measured after surgery
Secondary Objectives

Complications in operating room, recovery room, ICU and neurosurgery ward

Complications after hospital discharge

Length of stay in ICU is measured

Length of stay in hospital is measured

Mortality during hospitalization or 1 month after surgery

Mortality during 6 months after surgery

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical SciencesTehran, Iran, Islamic Republic ofSee the location
Suspended
Shohada Tajrish HospitalTehran, Iran, Islamic Republic of
Completed2 Study Centers