Rapid Normalization of Vitamin D Deficiency in PICU

Summary

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.

Conditions

• Vitamin D Deficiency

Interventions

DRUG

Cholecalciferol

Single enteral cholecalciferol load at a dose of 10,000 IU/kg (maximum 400,000 IU)

OTHER

Placebo

Single enteral placebo dose equivalent in volume to the appropriate weight-based dose of cholecalciferol

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• EURO-PHARM International Canada, Inc.

  collaborator OTHER

• Canadian Critical Care Trials Group

  collaborator OTHER

• Children's Hospital of Eastern Ontario

  lead OTHER

Principal Investigators

• Dayre McNally, MD, PhD · Children's Hospital of Eastern Ontario

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-17

Primary Completion

2024-10-17

Completion

2024-10-17

Countries

• Canada

Study Locations