The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy

The Effect of Single High Dose of Vitamin D3 on Short-term Postoperative Pain in Patients Under Craniotomy for Brain Tumor Resection

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.

Study Overview

• Status: Completed
• Conditions: Brain Neoplasms
• Intervention / Treatment: Drug: vitamin D

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (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 hyperparathyroidism
• Medications that interfere with vitamin D metabolism
• Renal Insufficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

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	Drug: vitamin D; Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection; Other Names: Cholecalciferol
No Intervention: control; Control patients will not be received any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to three days after surgery

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Investigators: Study Chair: Zahra Vahdat Shariatpanahi, MD, PhD, Faculty of Nutrition and Food Technology,

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: July 29, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Central Nervous System Neoplasms; Nervous System Neoplasms; Pain, Postoperative; Brain Neoplasms; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 1397.271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No