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

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.

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Key information

Conditions

Brain Neoplasms Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

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

Other names: Cholecalciferol

Primary outcomes

Short-term postoperative pain: measured by the visual analogue scale or visual analog scale (VAS) that is a pain rating scale

Time frame: Up to three days after surgery

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.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Aug 3, 2018
Registry last updated: Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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