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临床试验/NCT00168623
NCT00168623Unknown4 期

Randomised Trial of Vitamin A Supplementation Given With Routine Childhood Vaccines at National Immunisation Days

Bandim Health Project1 个研究点 分布在 1 个国家目标入组 6,200 人开始时间: 2003年11月最近更新:
适应症
相关药物

试验速览

阶段
4 期
入组人数
6,200
试验地点
1
主要终点
Mortality

研究概览

简要总结

Vitamin A supplementation (VAS) is important for the immune system and may interact with different childhood vaccinations. We have hypothesized that the improved survival after VAS may depend on vitamin A amplifying the non-specific immune modulation induced by vaccinations.

In the present study we used information collected in connection with a national vitamin A campaign in Guinea-Bissau during which different doses of VAS was provided together with missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions between VAS and vaccine type.

详细描述

Vitamin A supplementation (VAS) acts as an adjuvant to vaccines, and VAS has been shown to enhance both cellular and humoral immune responses in animals and in humans. Routine childhood vaccinations have recently been shown to have important non-targeted effects on mortality, i.e. effects that cannot be explained merely by the prevention of the targeted disease. We have hypothesized that the improved survival after VAS may depend not only on the prevention of vitamin A deficiency, but also on vitamin A amplifying the non-specific immune modulation induced by routine vaccinations.

In the present study we used information collected in connection with a national vitamin A campaign in Guinea-Bissau during which different doses of VAS was provided together with missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions between VAS and vaccine type.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between 6 months and 5 years and thus eligible for vitamin A and missing vaccines during national immunisation days -

排除标准

  • Overt signs of vitamin A deficiency

结局指标

主要结局

Mortality

Morbidity

Both outcomes analysed according to vaccine received and sex

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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