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

NCT ID: NCT03614403

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-30
• Study Completion Date: 2018-11-30

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.

Conditions

Brain Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vitamin D

Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection

Group Type: EXPERIMENTAL

vitamin D

Intervention Type: DRUG

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

control

Control patients will not be received any intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

vitamin D

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

Intervention Type: DRUG

Other Intervention Names

Cholecalciferol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University

OTHER

Sponsor Role: lead

Responsible Party

Zahra Vahdat Shariatpanahi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zahra Vahdat Shariatpanahi, MD, PhD

Role: STUDY_CHAIR

Faculty of Nutrition and Food Technology,

Locations

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

Tehran, , Iran

Countries

Iran

Other Identifiers

1397.271

Identifier Type: -

Identifier Source: org_study_id