Brain Neoplasms
Conditions
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.
Interventions
DRUGvitamin D
Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
Sponsors
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Iran
Outcome results
None listed