Efficacy and Safety of Vitamin A Treatment for Children With Sepsis: a Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 主要终点
- length of hospital stay
研究概览
简要总结
The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.
详细描述
It was reported that the prevalence of vitamin A deficiency was highly as 58% in critically ill children with sepsis. However, whether those patients will benefit from the vitamin A supplementation is unknown. We design an randomized, double-blind, placebo-controlled, multi-center trial to investigate the effect of vitamin A supplementation on the outcome of critically ill children with sepsis.
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, Care Provider)
入排标准
- 年龄范围
- 0 Months 至 192 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age < 18 years,
- •Expected to stay in the ICU for 48 hours or more,
- •Vitamin A deficiency (VA < 0.2 mg/L)
排除标准
- •Severely impaired gastrointestinal function
- •Premature infants and low birth weight (LBW) infants
- •Condition of underlying organ dysfunction
- •Having received chemotherapy or radiotherapy
- •Hematological malignancies
- •Primary or acquired immunodeficiency
研究组 & 干预措施
intervention group
Septic children with vitamin A deficiency who will receive vitamin A supplementation.
干预措施: Vitamin A (Drug)
control group
Septic children with vitamin A deficiency who will receive placebo.
干预措施: Oil (Drug)
结局指标
主要结局
length of hospital stay
时间窗: 2 years
The length of hospital stay will be measured by days
次要结局
- hospital mortality(2 years)