NCT03742505: VITdALIZE-KIDS

Rapid Normalization of Vitamin D Deficiency in PICU

Completed Phase 3 Last updated 12 February 2025

What this trial tests

Phase 3 trial testing Cholecalciferol in Vitamin D Deficiency in 424 participants. Completed in 17 October 2024.

Timeline

17 June 2019

Primary endpoint
17 October 2024

17 October 2024

Quick facts

Lead sponsor	Children's Hospital of Eastern Ontario
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	424
Start date	17 June 2019
Primary completion	17 October 2024
Estimated completion	17 October 2024
Sites	10 locations across Canada

Drugs / interventions tested

• Cholecalciferol (cholecalciferol) — full drug profile →
• Placebo

Conditions studied

• Vitamin D Deficiency — all drugs for Vitamin D Deficiency →

Sponsor

Children's Hospital of Eastern Ontario

Who can join

Under 17, any sex, with Vitamin D Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Vitamin D plays an important role in calcium balance, heart and lung health, inflammation, infection prevention, and muscle strength. Due to these roles, it has been suggested that critically ill patients with low vitamin D levels might have higher rates of death and worse long-term health. We believe that identifying critically ill children with vitamin D deficiency and then restoring vitamin D levels quickly could represent a safe, easy and inexpensive means of reducing patient illness, preventing death and improving quality of life. This clinical trial will determine whether rapid normalization of vitamin D deficiency improves survival and health-related quality of life following critical illness. The VITdALIZE-KIDS trial is a multicentre randomized clinical trial in Canadian Pediatric Intensive Care Units (PICUs). Critically ill children who agree to participate (consent given by caregivers) will have their blood vitamin D level measured, and those who are vitamin D deficient will be randomized to receive a single dose of either high-dose vitamin D3 or placebo (no drug).

Study participants assigned to the high-dose vitamin D arm will receive 10,000 IU/kg of enteral cholecalciferol (up to a maximum of 400,000 IU). We have tested this dose in a pilot trial, and no patient experienced serious adverse events related to vitamin D administration. Patients will be followed for 90 days to determine whether they survived and had a significant change in their health and quality of life. Vitamin D deficiency is a common problem not only among critically ill Canadian children, but in PICUs worldwide. In addition to being applicable in Canada, our study protocol was designed to be generalizable and meaningful to critically ill children worldwide.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age.
   Huey SL, Acharya N, Silver A, Sheni R, et al · · 2020 · cited 30× · PMID 33305842 · DOI 10.1002/14651858.cd012875.pub2
2. An update of the effects of vitamins D and C in critical illness.
   Hill A, Starchl C, Dresen E, Stoppe C, et al · · 2022 · cited 12× · PMID 36726354 · DOI 10.3389/fmed.2022.1083760
3. A high-throughput platform for the rapid screening of vitamin D status by direct infusion-MS/MS.
   Helmeczi E, Fries E, Perry L, Choong K, et al · · 2022 · cited 6× · PMID 35337847 · DOI 10.1016/j.jlr.2022.100204
4. Barriers, Solutions, and Opportunities for Adapting Critical Care Clinical Trials in the COVID-19 Pandemic.
   Cook D, Taneja S, Krewulak K, Zytaruk N, et al · · 2024 · cited 5× · PMID 38995645 · DOI 10.1001/jamanetworkopen.2024.20458
5. A phase II dose evaluation pilot feasibility randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study).
   O'Hearn K, Menon K, Weiler HA, Amrein K, et al · · 2023 · cited 5× · PMID 37580663 · DOI 10.1186/s12887-023-04205-9
6. Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter randomized controlled trial.
   O'Hearn K, Menon K, Albrecht L, Amrein K, et al · · 2024 · cited 4× · PMID 39300483 · DOI 10.1186/s13063-024-08461-7
7. The Role of Vitamin D and Vitamin D Receptor in Sepsis.
   Shang S, Chen D, Wei Y, Zou S, et al · · 2025 · cited 2× · PMID 40728969 · DOI 10.3390/cimb47070500