Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery
Primary Purpose
Brain Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
vitamin D
control
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms focused on measuring vitamin D, Brain Neoplasms, perioperative complications, clinical outcomes, craniotomy, Immune System
Eligibility Criteria
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
Sites / Locations
- Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
- Shohada Tajrish Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
vitamin D
control
Arm Description
Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection
Control patients will not be received any intervention
Outcomes
Primary Outcome Measures
Vitamin D level
25(OH) will be measured after surgery
Secondary Outcome Measures
Peri-operative Complications
Complications in operating room, recovery room, ICU and neurosurgery ward
Post-operative Complications
Complications after hospital discharge
Duration of stay in ICU
Length of stay in ICU is measured
Duration of stay in hospital
Length of stay in hospital is measured
1-month mortality
Mortality during hospitalization or 1 month after surgery
6-month mortality
Mortality during 6 months after surgery
Full Information
NCT ID
NCT03248544
First Posted
August 10, 2017
Last Updated
July 29, 2018
Sponsor
Shahid Beheshti University
1. Study Identification
Unique Protocol Identification Number
NCT03248544
Brief Title
Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
Keywords
vitamin D, Brain Neoplasms, perioperative complications, clinical outcomes, craniotomy, Immune System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D
Arm Type
Experimental
Arm Description
Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection
Arm Title
control
Arm Type
Other
Arm Description
Control patients will not be received any intervention
Intervention Type
Drug
Intervention Name(s)
vitamin D
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Vitamin D level
Description
25(OH) will be measured after surgery
Time Frame
Postoperative day 5
Secondary Outcome Measure Information:
Title
Peri-operative Complications
Description
Complications in operating room, recovery room, ICU and neurosurgery ward
Time Frame
During surgery, recovery and hospitalization (5 days post op)
Title
Post-operative Complications
Description
Complications after hospital discharge
Time Frame
30 days after surgery
Title
Duration of stay in ICU
Description
Length of stay in ICU is measured
Time Frame
30 days
Title
Duration of stay in hospital
Description
Length of stay in hospital is measured
Time Frame
30 days
Title
1-month mortality
Description
Mortality during hospitalization or 1 month after surgery
Time Frame
30 days
Title
6-month mortality
Description
Mortality during 6 months after surgery
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahra Vahdat Shariatpanahi, MD, PhD
Organizational Affiliation
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Shohada Tajrish Hospital
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33487259
Citation
Hajimohammadebrahim-Ketabforoush M, Shahmohammadi M, Keikhaee M, Eslamian G, Vahdat Shariatpanahi Z. Single high-dose vitamin D3 injection and clinical outcomes in brain tumor resection: A randomized, controlled clinical trial. Clin Nutr ESPEN. 2021 Feb;41:153-159. doi: 10.1016/j.clnesp.2020.11.027. Epub 2021 Jan 2.
Results Reference
derived
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Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery
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