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OpenTrials
Completed

NCT Number: NCT03248544

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

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.

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Key information

Conditions

Brain Neoplasms Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

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

Other names: Cholecalciferol

Control

Other

No intervention

Primary outcomes

  1. Vitamin D level

    Time frame: Postoperative day 5

    25(OH) will be measured after surgery

Secondary outcomes

  1. Peri-operative Complications

    Time frame: During surgery, recovery and hospitalization (5 days post op)

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

  2. Post-operative Complications

    Time frame: 30 days after surgery

    Complications after hospital discharge

  3. Duration of stay in ICU

    Time frame: 30 days

    Length of stay in ICU is measured

  4. Duration of stay in hospital

    Time frame: 30 days

    Length of stay in hospital is measured

  5. 1-month mortality

    Time frame: 30 days

    Mortality during hospitalization or 1 month after surgery

  6. 6-month mortality

    Time frame: 6 months

    Mortality during 6 months after surgery

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2017
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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