Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial
Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
Summary
Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory health,
inflammation, innate immunity, and neuromuscular function have led to the hypothesis that
deficiency might represent a modifiable risk factor for outcomes in critical illness. In
recent years, dozens of adult studies have reported both high deficiency rates, and
associations between lower vitamin D levels and organ dysfunction, health resource
utilization, and mortality in the intensive care unit (ICU). More recently, similar
observations have been made in critically ill pediatric populations. The cumulative body of
basic science and clinical literature demonstrates that deficiency is common in critical
illness and rapid normalization of vitamin D status could improve clinical outcomes and/or
reduce health care costs. However, before conducting a phase III trial to determine whether
restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing regimen
must be identified. Consequently, the investigators propose a phase II, double blind
randomized controlled trial to determine a loading therapy dosing regimen that can safely and
rapidly normalize vitamin D status in critically ill children.
Phase:
Phase 2
Details
Lead Sponsor:
Children's Hospital of Eastern Ontario
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins