Randomised Study of the Impact of Different Doses of Vitamin A on Childhood Morbidity and Mortality
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5,400
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio vaccine in national campaigns. However, it is not clear which dose is optimal. The two studies that have investigated the impact of different doses of vitamin A have both found that a smaller dose was better than a large dose. We therefore investigated if a smaller dose given with oral polio vaccine gives equal or better effect.
详细描述
Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause mortality with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination contacts. The currently recommended doses to be administered every 3-6 months are 100,000 IU for infants between 6 and 11 months of age and 200,000 IU for children 12 months and older. There is no clear evidence that a large dose is better than a small dose, the tendency being the opposite in the two studies of different doses of VAS that have been published so far.
With the global effort to eradicate polio, national immunization days with oral polio vaccine (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we aimed to examine whether the dose of vitamin A currently recommended by WHO or half this dose gives a better protection against childhood morbidity and mortality.
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 mo and 5 years old and thus eligible for OPV and vitamin A during national immunisation day
排除标准
- •Children with overt signs of vitamin A deficiency will not be enrolled in the study, but treated according to the recommendations. -
结局指标
主要结局
Mortality
Hospitalisations
Morbidity
Growth
次要结局
- Rotavirus infection