The Benefits and Risks of Iron interventionS in Children (BRISC) trial: Statistical analysis plan [version 1; peer review: 2 approved]

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, la...

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Published in:F1000 research 2020, Vol.9, p.427-427
Main Authors: Braat, Sabine, Larson, Leila, Simpson, Julie A, Hasan, Mohammed Imrul, Hamadani, Jena Derakhshani, Hossain, Sheikh Jamal, Shiraji, Shamima, Bhuiyan, Mohammad Saiful Alam, Biggs, Beverley-Ann, Pasricha, Sant-Rayn
Format: Article
Language:English
Subjects:
Age
anaemia
Anemia
Bayley Scales
Child development
Children
Children & youth
Clinical trials
cognition
Cognitive development
eng
Hematology
Hemoglobin
Households
Infections
Intervention
Iron
Iron deficiency
Laboratories
Morbidity
Nutrient deficiency
Proteins
randomised control trial
Statistical analysis
Statistics
Study Protocol
Supplements
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Summary: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.
ISSN:2046-1402
2046-1402
DOI:10.12688/f1000research.23383.1