Benefits and Risks of Iron Supplementation and Multiple Micronutrient Powders in Children: a three arm, individually randomized controlled trial in Bangladesh

niversity of Melbourne0 个研究点目标入组 3,300 人开始时间: 2017年5月8日最近更新: 2020年3月23日

试验速览

暂无简介。

•Each participant must meet all of the following criteria to be enrolled in this study:
•-Is aged 8 months (+/-14 days) at the time of randomisation
•-Is not expected to leave the study site (leave local village or the Rupganj area) for more than 1 week over the next 3 months, or for more than one month over the next 12 months.
•-Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.

•Children meeting any of the following criteria will be excluded from the study:
•- Has a capillary Hb at screening of <8.0g/dL at the time of screening
•- Drinking water iron level >1gm/L
•- Has an established diagnosis of any homozygous or compound heterozygous haemoglobinopathies (i.e. beta thalassaemia major, HbE-beta thalassaemia).
•- Current infective illness with fever (respiratory infection, diarrhoea); however, children will be screened again after recovery and recruited as long as the meet the age eligibility criteria at second screening.
•- Legal guardian unwilling or unable to provide written informed consent.
•- Has not received iron supplements or iron-containing multiple micronutrient powders in the previous month. Families who self-procure iron/MMP during or after the intervention period will not be dropped from the study, but we will record the dose and duration and continue monitoring
•- Known congental anomaly, developmental disorder or severe developmental delay
•- It is not possible to test the child due to physical or behavioural problems
•- Children of multiple birth e.g. twin, triplets

发起方

niversity of Melbourne