EUCTR2016-002460-13-GB进行中（未招募）1 期
Effect of High-Dose Vitamin D3 on 28-Day Mortality in Adult Critically Ill Patients with Severe Vitamin D DeficiencyThe UK arm of an International Multi-Centre, Placebo-Controlled, Phase III Double-Blind trial - VITDALIZE UK
Medical Unviersity of Graz0 个研究点目标入组 2,400 人开始时间: 2020年9月25日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients =18 years
- •2. Anticipated ICU stay = 48 hours
- •3. Admission to ICU = 72 hours before screening for VDD
- •4. Severe VDD (25(OH)D =12ng/ml (30nmol/L)) using either the hospital's clinical laboratory or rapid bedside testing after ICU admission
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Severe gastrointestinal dysfunction (>400ml nasogastric tube residual volume) /unable to receive trial medication
- •2. Not expected to survive initial 48 hours of admission or treatment withdrawal imminent within 24 hours.
- •3. Patient with DNAR (Do Not Attempt Resuscitation) orders in place
- •4. Hypercalcemia (>2.65mmol/l corrected calcium and/or >1.35mmol/l ionized calcium at screening)
- •5. Known kidney stones within the last 12 months
- •6. Known active tuberculosis within the last 12 months
- •7. Known sarcoidosis within the last 12 months
- •8. Women of child bearing age who have tested positive for pregnancy or who are lactating
- •9. Known hypersensitivity to the trial drug or excipient
- •10. Medical team deem it not suitable to include patient
- •11. Known prisoners in the custody of HM Prison and Probation services
研究者
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