Study design and participants
chronic kidney diseaseThe
RECRUITMENT
The HOT-KID study was a parallel-group, open-label, multicentre, randomised, controlled trial. We also completed an observational study as part of HOT-KID, but the results of this study will be reported at a later date. The randomised controlled trial was done at 14 clinical centres across England and Scotland. Children aged 2–15 years were included if they had stage 1–4 chronic kidney diseaseThe trial design complies with the principles of the Declaration of Helsinki and was approved by the Clinical Studies Group of the British Association for Paediatric Nephrology, with recruitment and follow-up supported by all paediatric nephrology centres in the UK. Parents or legal guardians of children gave written informed consent, and participants gave assent as appropriate. Trial participants were enrolled by the study site principal investigator with any queries regarding eligibility discussed with chief investigator (MDS). The study protocol (incorporating the randomised controlled trial) had no additional amendments to that included in the 