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临床试验/NCT03639584
NCT03639584已完成不适用

Investigating the Prevalence of Deficiency of Vitamin D in Critically Ill Patients and Its Effects on the Prognosis

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 662 人开始时间: 2018年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
662
试验地点
1
主要终点
The prevalence of Vitamin D deficiency

研究概览

简要总结

Vitamin D has been shown to related to clinical outcomes in critically ill patients. The object of this study is to investigate the prevalence of Vitamin D deficiency in critically ill patients with various length of ICU stay .

详细描述

Studies have revealed that the serum level of 25-hydroxyvitamin D, as known as calcidiol, is low in critically ill patients. The prevalence ranges from 26 to 82%. 25-hydroxyvitamin D deficiency is associated with longer ICU stay, higher medical cost and higher death rate in septic patients. 25-hydroxyvitamin D is a kind of hormone related to bone and mineral metabolism. Moreover, the receptors were found in almost all cells, and it is related to immune system, cytokine release, cellular proliferation and differentiation, angiogenesis, and muscular energy. The main source is skin metabolism triggered by sunshine and food consumption. It is subsequently converted to calcifediol in the liver and then calcitriol in the kidney (the active form). Its serum level is regulated by parathyroid hormone and serum calcium and phosphate. The critically ill patients are deprived of sunshine, suffered from poor nutrition support, impaired liver and kidney function, higher rate of consumption, and are under higher risk of deficiency. Nowadays, the studies about 25-hydroxyvitamin D in ICU patients were conducted mostly in Europe and America. There is no large-scale study in Taiwan or Asia. A randomized controlled study from Austria has shown large dose supply in patients with 25-hydroxyvitamin D deficiency could decrease the mortality.

The object of this multi-center study is to investigate the prevalence of 25-hydroxyvitamin D deficiency, the risk factors and the correlation with outcomes. The results could be a step-stone for future randomized controlled studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All ICU patients

排除标准

  • 1, Less than 20 years 2, BMI < 18 kg/m^2 3, Had large dose vit D within previous four weeks (over 3000 IU per day) 4, ICU admission within previous three months 5, Have disease affecting vit D level, calcium metabolism, bone metabolism such as parathyroid disease, Rickets, liver cirrhosis child C 6, Communication difficulty

结局指标

主要结局

The prevalence of Vitamin D deficiency

时间窗: 1 day at enrollment

Investigate the prevalence of vitamin D deficiency among groups

次要结局

  • Difference of mortality on 28th and 90th day in group 2(90 days)
  • Difference of 28-day ventialtor-free days(28 days)
  • Difference of mortality on 28th and 90th day in group 3, 4, and 5(90 days)
  • Serial changes of serum vitamin D levels in group 2(28 days)
  • Difference of 28-day ICU-free days(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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