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

Sponsor
Shahid Beheshti University (Other)
Overall Status
Completed
CT.gov ID
NCT03614403
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
16
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: vitamin D
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Single High Dose of Vitamin D3 on Short-term Postoperative Pain in Patients Under Craniotomy for Brain Tumor Resection
Actual Study Start Date :
Jul 30, 2017
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Nov 30, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

    • Shahid Beheshti University

    Investigators

    • Study Chair: Zahra Vahdat Shariatpanahi, MD, PhD, Faculty of Nutrition and Food Technology,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zahra Vahdat Shariatpanahi, Associate Professor, Shahid Beheshti University
    ClinicalTrials.gov Identifier:
    NCT03614403
    Other Study ID Numbers:
    • 1397.271
    First Posted:
    Aug 3, 2018
    Last Update Posted:
    Apr 9, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Neoplasms
    Pain, Postoperative
    Vitamin D
    Cholecalciferol

    Study Results

    No Results Posted as of Apr 9, 2019