NCT01130181已完成3 期
Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial ("VITDAL@ICU")
Harald Dobnig, MD1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
Study hypothesis:
High-dose vitamin D leads to a shorter hospital stay in critically ill patients
Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo.
详细描述
Inclusion criteria
- Age ≥18 years
- expected ICU stay ≥48 hours
- vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
- feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible
Exclusion criteria
- moribund patient expected to die within 24 hours
- hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
- severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)
- known history of recent kidney stones (≤ 1 year)
- known granulomatous diseases (tuberculosis, sarcoidosis)
- pregnancy
Primary endpoint
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, Care Provider, Investigator)
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
- •Age ≥18 years
- •expected ICU stay ≥48 hours
- •vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
- •feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible
排除标准
- •moribund patient expected to die within 24 hours
- •hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
- •severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)
- •known history of recent kidney stones (≤ 1 year)
- •known granulomatous diseases (tuberculosis, sarcoidosis)
- •pregnancy
研究组 & 干预措施
Cholecalciferol
Experimental
干预措施: Cholecalciferol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Length of hospital stay
时间窗: maximum 6 months
The length of hospital stay will be compared between the two groups (starting from application of the study medication; end is defined as death of the patient or hospital discharge) Survivors and non-survivors will also be analysed separately. Stay in rehabilitation facilities will not be counted.
次要结局
- 25(OH)D levels(maximum 6 months)
- calcium levels(maximum 6 months)
- hospital mortality, 28-day mortality, 6 month-mortality(maximum 6 months)
- length of ICU stay starting from application of study medication(until patient's death or referral to another ward)
- duration of mechanical ventilation(starting from application of study medication)
研究者
Harald Dobnig, MD
Professor
Medical University of Graz
研究点 (1)
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