The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy
Primary Purpose
Brain Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms
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 hyperparathyroidism
- Medications that interfere with vitamin D metabolism
- Renal Insufficiency
Sites / Locations
- Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
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
Short-term postoperative pain: measured by the visual analogue scale or visual analog scale (VAS) that is a pain rating scale
By questioning from patients for daily pain intensity based on the VAS scale in which pain intensity score by 0 to 10. The "0" and "10" score indicates "no pain" and "worst pain",respectively. also "1-3" , "4-6" and "7-9" score indicates mild, mild to moderate and severe pain, respectively.
Secondary Outcome Measures
Full Information
NCT ID
NCT03614403
First Posted
July 29, 2018
Last Updated
April 8, 2019
Sponsor
Shahid Beheshti University
1. Study Identification
Unique Protocol Identification Number
NCT03614403
Brief Title
The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy
Official Title
The Effect of Single High Dose of Vitamin D3 on Short-term Postoperative Pain in Patients Under Craniotomy for Brain Tumor Resection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 30, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 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
5. Study Description
Brief Summary
Vitamin D is a hormone mainly synthesized in the skin in the presence of sunlight. Like other hormones, vitamin D plays a role in a wide range of processes in the body. Some studies have shown vitamin D has anti-inflammatory effects in the body by reducing the release of pro-inflammatory cytokines and suppressing T-cell responses. Therefore, vitamin D may be effective on reduce pain by such mechanisms. In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to the control group.
Detailed Description
A randomized, double blind, controlled trial will be conducted in intensive care unit (ICU) and neurosurgery ward, in Shohada-E-Tajrish hospital,Tehran, Iran. First, patients will be carefully checked for inclusion and exclusion criteria. Then, the eligible patients will complete the consent form for this study. 60 eligible brain tumor patients diagnosed by surgeon that are ready for craniotomy will be selected.These patients will be divided into two groups. Intervention group will be received an intramuscular (IM) single dose of vitamin D (300000 IU),while another group will not receive. Pain in patients will be checked daily by up to 3 days after surgery. Finally, the VAS pain score will be compared in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
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
No Intervention
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
Primary Outcome Measure Information:
Title
Short-term postoperative pain: measured by the visual analogue scale or visual analog scale (VAS) that is a pain rating scale
Description
By questioning from patients for daily pain intensity based on the VAS scale in which pain intensity score by 0 to 10. The "0" and "10" score indicates "no pain" and "worst pain",respectively. also "1-3" , "4-6" and "7-9" score indicates mild, mild to moderate and severe pain, respectively.
Time Frame
Up to three days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 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 hyperparathyroidism
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,
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy
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