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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Vitamin D level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent of patient or legal representative
- •25(OH)D level below 20ng/dL
排除标准
- •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
研究组 & 干预措施
vitamin D
Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection
干预措施: vitamin D (Drug)
control
Control patients will not be received any intervention
干预措施: control (Other)
结局指标
主要结局
Vitamin D level
时间窗: Postoperative day 5
25(OH) will be measured after surgery
次要结局
- Duration of stay in ICU(30 days)
- Duration of stay in hospital(30 days)
- 1-month mortality(30 days)
- 6-month mortality(6 months)
- Peri-operative Complications(During surgery, recovery and hospitalization (5 days post op))
- Post-operative Complications(30 days after surgery)
研究者
Zahra Vahdat Shariatpanahi
Associate Professor
Shahid Beheshti University