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临床试验/NCT02936895
NCT02936895已完成4 期

The Effects of Vitamin D Supplementation in Respiratory Index of Severity in Children (RISC) of Hospitalized Patients With Community-acquired Pneumonia

Hormozgan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Respiratory Index of Severity in Children (RISC)

研究概览

简要总结

Childhood deaths from pneumonia is almost 2000 times higher in developing countries than in developed countries. In 1970, pneumonia was responsible for 9% of all deaths in children under 5 years. This rate was 2% in 2007.

Some studies have shown that supplementing with vitamin D reduces disease of the respiratory tract infection. Some other studies have shown anti-inflammatory effect of vitamin D in cell lines. Studies about the role of vitamin D supplementation in pneumonia in children are inadequate to conclude about its role.

The aim of this study is to determine the efficacy of vitamin D supplementation in Respiratory Index of Severity in Children (RISC) hospitalized clinical outcomes of hospitalized patients with community-acquired pneumonia.

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
Double (Participant, Investigator)

入排标准

年龄范围
2 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo (same size and shape) for 2 days

干预措施: Placebo (Drug)

Vitamin D3 (Low dose)

Experimental

vitamin D at a dose of 50,000 IU per day for 2 days

干预措施: Vitamin D3 (Drug)

结局指标

主要结局

Respiratory Index of Severity in Children (RISC)

时间窗: through study completion, an average of 4 days

For determining severity of pneumonia, RISC (Respiratory Index of Severity in Children) scoring system was used, including oxygen saturation, chest retraction, wheezing and refusal to feed, and also contains standards growth (weight for age).

次要结局

  • Duration of hospitalization(through study completion, an average of 4 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hamidreza Mahboobi

Dr

Hormozgan University of Medical Sciences

研究点 (1)

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