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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
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 29, 2018
Last Updated
April 8, 2019
Sponsor
Shahid Beheshti University
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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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