Data monitoring and harm assessment
SAEs
RECRUITMENT
An iDSMC was established prior to any participant recruitment. The committee includes experienced study independent statisticians, clinicians, endocrinologists and epidemiologists. SAEs (hospital admissions) and other AEs are monitored by study staff through hospital visits, participant contact and regular review of participant medical records. Each SAE is reported to an independent medical monitor (an experienced paediatrician not on the iDSMC) to review causality. SAEs deemed as potentially related to the study are reported to the iDSMC and Human Research Ethics Committee (HREC) within 72 hours. At regular intervals (<6 months), the iDSMC assess the totality of information relating to participant recruitment and retention, protocol deviations and violations, AEs and SAEs. Unblinding can be requested where concerns arise. With compelling evidence, the iDSMC can recommend cessation of the trial. Given vitamin D is low risk, there are no predefined stopping rules or planned interim analyses. A First Nations Reference Group oversees cultural aspects of the study.