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

Brain Neoplasms Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248544
• Other study ID #: 1396-607
• Status: Completed
• Phase: N/A
• Start date: July 6, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: July 2018
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Postoperative Complications

Intervention

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

Other:
• control
No intervention

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences	Tehran
Iran, Islamic Republic of	Shohada Tajrish Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D level	25(OH) will be measured after surgery	Postoperative day 5
Secondary	Peri-operative Complications	Complications in operating room, recovery room, ICU and neurosurgery ward	During surgery, recovery and hospitalization (5 days post op)
Secondary	Post-operative Complications	Complications after hospital discharge	30 days after surgery
Secondary	Duration of stay in ICU	Length of stay in ICU is measured	30 days
Secondary	Duration of stay in hospital	Length of stay in hospital is measured	30 days
Secondary	1-month mortality	Mortality during hospitalization or 1 month after surgery	30 days
Secondary	6-month mortality	Mortality during 6 months after surgery	6 months