Iwk Health Centre

VITdALIZE-KIDS Trial Assesses Vitamin D Supplementation Impact on Pediatric ICU Patients' Quality of Life

8 months ago

• The VITdALIZE-KIDS trial is a phase III, multicenter, randomized, double-blind study evaluating high-dose vitamin D supplementation in critically ill children with vitamin D deficiency. • The primary outcome is health-related quality of life (HRQL) measured by the PedsQL™ scale at 28 days post-intervention, with secondary outcomes including hospital length of stay and adverse events. • The trial aims to enroll 766 patients across 11 Canadian PICUs, randomizing them to either a high-dose cholecalciferol bolus or a placebo, with a metabolomics sub-study planned for a subset. • Interim analyses are scheduled to assess efficacy and safety, with a DSMB providing oversight and the potential for early termination based on futility or safety concerns.