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

Brain Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614403
• Other study ID #: 1397.271
• Status: Completed
• Phase: N/A
• Start date: July 30, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2019
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Pain, Postoperative

Intervention

Drug:
• vitamin D
Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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