1. Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter randomized controlled trial
- Author
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Katie O’Hearn, Kusum Menon, Lisa Albrecht, Karin Amrein, Philip Britz-McKibbin, Florence Cayouette, Karen Choong, Jennifer Ruth Foster, Dean A. Fergusson, Alejandro Floh, Patricia Fontela, Pavel Geier, Elaine Gilfoyle, Gonzalo Garcia Guerra, Anna Gunz, Erick Helmeczi, Ali Khamessan, Ari R. Joffe, Laurie Lee, Lauralyn McIntyre, Srinivas Murthy, Simon J. Parsons, Tim Ramsay, Lindsay Ryerson, Marisa Tucci, Dayre McNally, and the Canadian Critical Care Trials Group
- Subjects
Vitamin D ,Pediatrics ,Critical care ,Randomized controlled trial ,Vitamin D deficiency ,Health-related quality of life ,Medicine (General) ,R5-920 - Abstract
Abstract Background The rate of vitamin D deficiency (VDD) in critically ill children worldwide has been estimated at 50%. These children are at risk of multiple organ dysfunction, chronic morbidity, and decreased health related quality of life (HRQL). Pediatric and adult ICU clinical trials suggest that VDD is associated with worse clinical outcomes, although data from supplementation trials are limited and inconclusive. Our group’s phase II multicenter dose evaluation pilot study established the efficacy and safety of an enteral weight-based cholecalciferol loading dose to rapidly restore vitamin D levels in critically ill children. Methods Our aim is to evaluate the impact of this dosing regimen on clinical outcomes. VITdALIZE-KIDS is a pragmatic, phase III, multicenter, double-blind RCT aiming to randomize 766 critically ill children from Canadian PICUs. Participants are randomized using a 1:1 scheme to receive a single dose at enrollment of enteral cholecalciferol (10,000 IU/kg, max 400,000 IU) or placebo. Eligibility criteria include critically ill children aged newborn (> 37 weeks corrected gestational age) to
- Published
- 2024
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