- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03248544
Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery
July 29, 2018 updated by: Zahra Vahdat Shariatpanahi, Shahid Beheshti University
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tehran, Iran, Islamic Republic of
- Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
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Tehran, Iran, Islamic Republic of
- Shohada Tajrish Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: vitamin D
Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection
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Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
Other Names:
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OTHER: control
Control patients will not be received any intervention
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No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D level
Time Frame: Postoperative day 5
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25(OH) will be measured after surgery
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Postoperative day 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peri-operative Complications
Time Frame: During surgery, recovery and hospitalization (5 days post op)
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Complications in operating room, recovery room, ICU and neurosurgery ward
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During surgery, recovery and hospitalization (5 days post op)
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Post-operative Complications
Time Frame: 30 days after surgery
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Complications after hospital discharge
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30 days after surgery
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Duration of stay in ICU
Time Frame: 30 days
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Length of stay in ICU is measured
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30 days
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Duration of stay in hospital
Time Frame: 30 days
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Length of stay in hospital is measured
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30 days
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1-month mortality
Time Frame: 30 days
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Mortality during hospitalization or 1 month after surgery
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30 days
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6-month mortality
Time Frame: 6 months
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Mortality during 6 months after surgery
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Zahra Vahdat Shariatpanahi, MD, PhD, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 6, 2017
Primary Completion (ACTUAL)
July 30, 2018
Study Completion (ACTUAL)
July 30, 2018
Study Registration Dates
First Submitted
August 10, 2017
First Submitted That Met QC Criteria
August 10, 2017
First Posted (ACTUAL)
August 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 31, 2018
Last Update Submitted That Met QC Criteria
July 29, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Brain Neoplasms
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- 1396-607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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