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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-06

Study Completion Date

2018-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy

NCT03614403

Brain Neoplasms

COMPLETED NA

Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Major Surgical Procedures.

NCT02138591

Vitamin d Deficiency

WITHDRAWN PHASE3

Can Vitamin D Reduce Heart Muscle Damage After Bypass Surgery?

NCT04323852

Vitamin D Deficiency Cardiomyopathies Apoptosis +1 more

COMPLETED PHASE4

Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy

NCT03536845

Epilepsy Vitamin D Deficiency

COMPLETED PHASE3

Prevention of Postoperative Hypocalcemia of Oral Vitamin D Supplementation Before Total Thyroidectomy

NCT05216419

Total Thyroidectomy Hypocalcemia Vitamin D Deficiency

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vitamin D

Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection

Group Type EXPERIMENTAL

vitamin D

Intervention Type DRUG

Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection

control

Control patients will not be received any intervention

Group Type OTHER

control

Intervention Type OTHER

No intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vitamin D

Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection

Intervention Type DRUG

control

No intervention

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cholecalciferol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No