ACTRN12620000386932进行中（未招募）3 期
Benefits and safety of IRon supplementation with MAlaria chemoprevention to children in Malawi (IRMA) - A randomised controlled trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 6 Months 至 6 Months（—）
- 性别
- All
入选标准
- •1.Infants aged 6 months (+/- 14 days) at the time of randomisation
- •2.Has a legally acceptable guardian/representative capable of understanding the informed consent document and providing consent on the participant’s behalf
排除标准
- •1.Severe anaemia (Hb<7g/dL) or
- •2.Current infective illness with fever (respiratory infection, diarrhoea, malaria); however, children will be screened again after recovery and recruited as long as they meet the age eligibility criteria at second screening
- •3.Severe malnutrition (weight-for-length z-score<-3);
- •4.Established diagnosis of haemoglobinopathy (e.g. sickle cell disease, beta thalassaemia major, HbE-beta thalassaemia).
- •5.Legal guardian unwilling or unable to provide written informed consent
- •6.Known congenital anomaly, developmental disorder or severe developmental delay
- •7.Children with physical or behavioural problems that will make it impossible to test the child
- •8.Children of multiple birth e.g. twin, triplets etc.
- •9.Currently consuming MNPs e.g. from the National MNP programme
研究者
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