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临床试验/NCT00168636
NCT00168636已完成4 期

The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality

Bandim Health Project1 个研究点 分布在 1 个国家目标入组 11,000 人开始时间: 2004年11月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
11,000
试验地点
1
主要终点
Mortality

研究概览

简要总结

We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for boys. The girls' response might have depended on the last vaccine received before the OPV and VAS campaign. We believe that these findings call for confirmation. In connection with a new campaign, we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

详细描述

In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we examined whether the half dose compared with the full dose currently recommended by WHO gave an equally good protection against childhood morbidity and mortality. Mortality after supplementation was lower, though not significantly so, for children who had received the half dose. However, there was a highly significant inversion of the effect for boys and girls; while the low dose was clearly better for girls, the full dose might have been slightly better for boys. The girls' responses to the high versus the low dose of vitamin A might have depended on the last vaccine received before the OPV and VAS campaign.

We believe that these findings call for confirmation. In connection with the OPV and VAS campaign in November 2004 in Guinea-Bissau, we intend to examined whether half the dose of the dose currently recommended by WHO as compared to the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

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 mo and 5 years of age and thus eligible for vitamin A and OPV campaign -

排除标准

  • Overt signs of vitamin A deficiency

结局指标

主要结局

Mortality

Morbidity

All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received

次要结局

  • Rota infection
  • Measles infection
  • Growth

研究者

申办方类型
Other

研究点 (1)

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