Abstract
Background: The Benefits and Risks of Iron interventionS in Children (BRISC) trial will evaluate the impact of universal supplementation with iron supplements or iron-containing multiple micronutrient powders (MNPs) compared with placebo given for 3 months on child development, growth, morbidity, laboratory indices of anaemia, iron deficiency, and inflammation at end of intervention and after a further 9 months post intervention in children aged 8 months living in rural Bangladesh. This paper describes the statistical analysis plan. Methods: BRISC is a multi-site, three-arm, double-dummy blinded, parallel group, randomised control superiority trial in 3300 children. The statistical analysis plan was developed by the trial statistician in consultation with the trial steering committee and trial management committee based on the protocol, data collection forms, and study outcomes available in the blinded study database. Conclusion: This detailed statistical analysis plan published prior to unblinding the allocated treatments will support the statistical analyses and reporting of the BRISC trial to be undertaken after unblinding. It allows for transparency as well as reproducibility of statistical analyses and reporting. Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000660381 (registered on 8 May 2017); World Health Organization Universal Trial Number U1111-1196-1125.
Highlights
The World Health Organization (WHO) recommends daily iron supplementation to all children aged 6–23 months residing in settings where anaemia prevalence is 40% or above, or alternatively, home fortification with ironcontaining multiple micronutrient powders where the prevalence of anaemia is 20% or above, with the goal of reducing anaemia and improving child development[1,2]
The Benefits and Risks of Iron interventionS in Children (BRISC) trial is a placebo-controlled, randomised trial undertaken in rural Bangladesh designed to examine the effect of universal provision of iron syrup or iron-containing micronutrient powders (MNPs) on child development, growth, morbidity from infections, and haematological and iron indices[6]
The primary objective of this study is to determine whether 3 months of iron supplementation or home fortification with MNPs is superior to placebo on cognitive development in 8-month old children at the end of the intervention
Summary
The World Health Organization (WHO) recommends daily iron supplementation to all children (universal provision) aged 6–23 months residing in settings where anaemia prevalence is 40% or above, or alternatively, home fortification with ironcontaining multiple micronutrient powders where the prevalence of anaemia is 20% or above, with the goal of reducing anaemia and improving child development[1,2]. There is limited evidence for the effects of iron supplementation on early child development[3,4]; in high infection burden settings, iron may promote infection, including diarrhoea[5]. The Benefits and Risks of Iron interventionS in Children (BRISC) trial is a placebo-controlled, randomised trial undertaken in rural Bangladesh designed to examine the effect of universal provision of iron syrup or iron-containing MNPs on child development, growth, morbidity from infections, and haematological and iron indices[6]. The planned analyses for the BRISC trial are described. Finalisation of the statistical analysis plan prior to study unblinding has been undertaken to ensure transparency in the methods used to analyse and report the data and create the evidence for the effects of iron supplementation on early child development, growth, haemoglobin, iron status and infection
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