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