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

NCT03614403 | Completed

• 1 other identifier: 1397.271
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Drug: vitamin D

control

NO INTERVENTION

Control patients will not be received any intervention

Interventions

vitamin D DRUG

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

Also known as: Cholecalciferol

Vitamin D

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent of patient or legal representative
• (OH)D level below 20ng/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

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

Tehran, Iran

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Zahra Vahdat Shariatpanahi, MD, PhD

  Faculty of Nutrition and Food Technology,

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 3, 2018
• Study Start: July 30, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)