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Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter
Katie O'Hearn1, Kusum Menon1,2, Lisa Albrecht1
1CHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Insights
This study investigates if rapid vitamin D normalization improves health-related quality of life in critically ill children. The VITdALIZE-KIDS trial aims to determine if this intervention enhances outcomes for pediatric patients with vitamin D deficiency.
Area of Science:
- Pediatric Critical Care Medicine
- Nutritional Science
- Clinical Trials
Background:
- Vitamin D deficiency (VDD) affects 50% of critically ill children globally, increasing risks of organ dysfunction and poor quality of life.
- Previous trials on vitamin D supplementation in ICUs have yielded inconclusive results regarding clinical outcomes.
- A pilot study demonstrated the efficacy of a weight-based enteral cholecalciferol loading dose for rapid vitamin D repletion in this population.
Purpose of the Study:
- To evaluate the clinical impact of a specific enteral cholecalciferol dosing regimen in critically ill children.
- To determine if rapid normalization of vitamin D status improves health-related quality of life (HRQL) at 28 days post-enrollment.
- To assess the effect of vitamin D repletion on multiple organ dysfunction and other secondary outcomes.
Main Methods:
- The VITdALIZE-KIDS trial is a phase III, multicenter, double-blind, randomized controlled trial involving 766 critically ill children (37 weeks corrected gestational age to <18 years) with VDD (<50 nmol/L).
- Participants receive either a single enteral dose of cholecalciferol (10,000 IU/kg, max 400,000 IU) or placebo at enrollment.
- Primary endpoint is HRQL at 28 days; secondary endpoints include multiple organ dysfunction, functional status, mortality, length of stay, and safety.
Main Results:
- This section is not yet available as the trial is ongoing.
- The study is actively recruiting participants from June 2019 to March 2026.
- A sub-study includes comprehensive vitamin D speciation and metabolite profiling for the first 100 participants.
Conclusions:
- The VITdALIZE-KIDS trial is the first phase III multicenter study to assess rapid vitamin D normalization for improving outcomes in pediatric critical illness.
- This trial will provide crucial data on the efficacy and safety of this intervention.
- The findings could establish a simple, inexpensive, and safe strategy to enhance recovery for critically ill children.
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 < 18 years who have blood total 25-hydroxyvitamin D < 50 nmol/L. The primary objective is to determine if rapid normalization of vitamin D status improves HRQL at 28 days following enrollment. The secondary objective is to evaluate the impact of rapid normalization of vitamin D status on multiple organ dysfunction. The study includes additional tertiary outcomes including functional status, HRQL and mortality at hospital discharge and 90 days, PICU and hospital length of stay, and adverse events related to vitamin D toxicity. Additionally, we are performing comprehensive vitamin D speciation and non-targeted metabolite profiling as part of a sub-study for the first 100 participants from whom an enrollment and at least one post-intervention blood and urine sample were obtained.
Discussion:
The VITdALIZE-KIDS trial is the first phase III, multicenter trial to evaluate whether rapid normalization of vitamin D status could represent a simple, inexpensive, and safe means of improving outcomes following pediatric critical illness. Recruitment was initiated in June 2019 and is expected to continue to March 2026.
Trial Registration:
Clinicaltrials.gov, NCT03742505. Study first submitted on November 12, 2018 https://clinicaltrials.gov/study/NCT03742505.
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