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

Last updated: July 29, 2018
Sponsor: Shahid Beheshti University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03248544
1396-607
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent of patient or legal representative

  • 25(OH)D level below 20ng/dL

Exclusion

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

Total Participants: 60
Study Start date:
July 06, 2017
Estimated Completion Date:
July 30, 2018

Study 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.

Connect with a study center

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

    Tehran,
    Iran, Islamic Republic of

    Site Not Available

  • Shohada Tajrish Hospital

    Tehran,
    Iran, Islamic Republic of

    Site Not Available

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