Clinical trial NCT03248544: Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery
Official title: Effect of Single High Dose Vitamin D3 on Peri-operative and Post-operative Complications and Clinical Outcomes in Patients Under Craniotomy for Brain Tumor Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Neoplasms
Keywords: vitamin D
Brain Neoplasms
perioperative complications
clinical outcomes
craniotomy
Immune System
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D supplementation not only has beneficial effects on morbidity and mortality in critically ill patients but it may also lead to alleviate of seizure, brain edema, infection, pain and some other perioperative complications, possibly in part through an attenuation of the immune response.In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to control group.

Detailed description: A randomized, double blind, controlled trial will be conducted in neurosurgery ward, operating room (OR) and intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 60 eligible hospitalized patients that diagnosed with brain tumor and need to craniotomy, aged ≥ 18 years. Intervention patients will be received an intramuscular (IM) single dose of vitamin D (300000 IU). Patients will be evaluated for occurrence of perioperative complications and clinical outcomes immediately after surgery until 1 month later and 1 and 6 months mortality.

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 hyperparathyroidis
* Medications that interfere with vitamin D metabolism
* Renal Insufficiency

Primary outcomes:
measure: Vitamin D level
timeFrame: Postoperative day 5
Secondary outcomes:
measure: Peri-operative Complications
timeFrame: During surgery, recovery and hospitalization (5 days post op)
measure: Post-operative Complications
timeFrame: 30 days after surgery
measure: Duration of stay in ICU
timeFrame: 30 days
measure: Duration of stay in hospital
timeFrame: 30 days
measure: 1-month mortality
timeFrame: 30 days
measure: 6-month mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
city: Tehran
country: Iran, Islamic Republic of
facility: Shohada Tajrish Hospital
Study officials:
affiliation: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Zahra Vahdat Shariatpanahi, MD, PhD
role: STUDY_CHAIR
References:
citation: Hajimohammadebrahim-Ketabforoush M, Shahmohammadi M, Keikhaee M, Eslamian G, Vahdat Shariatpanahi Z. Single high-dose vitamin D3 injection and clinical outcomes in brain tumor resection: A randomized, controlled clinical trial. Clin Nutr ESPEN. 2021 Feb;41:153-159. doi: 10.1016/j.clnesp.2020.11.027. Epub 2021 Jan 2.