跳至主要内容
临床试验/NCT00168649
NCT00168649Unknown不适用

The Effect of Vitamin A on the Response to Endotoxin

Bandim Health Project2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年6月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
TNF-alfa levels

研究概览

简要总结

Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. We furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses.

详细描述

Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. As studies in children in low-income countries have indicated that vitamin A has long-term effects on the immune system, we furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. This will be done in an established model using infusion with endotoxin to male human volunteers. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses. Furthermore, we hypothesise that it reduces oxidative stress and injury.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy, male, between 18 and 35 years of age, non-smoker, no medicine, no infections in preceding 14 days

排除标准

  • 未提供

结局指标

主要结局

TNF-alfa levels

Endotoxin levels

次要结局

  • Haematological values
  • Clinical markers
  • Retinol and beta-caroten levels
  • Measures of oxidative injury and stress

研究者

申办方类型
Other

研究点 (2)

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