Rapid Normalization of Vitamin D Deficiency in PICU

• Status: Recruiting
• Trial end date: 2025-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Eastern Ontario
• Collaborators: Canadian Critical Care Trials Group; Canadian Institutes of Health Research (CIHR); EURO-PHARM International Canada inc.; EURO-PHARM International Canada, Inc.
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Anticipated PICU stay ≥48 hours at the time of enrollment OR patient will be in PICU at time of study drug administration and has an expected hospital length of stay of ≥7 days

• Corrected gestational age 37 weeks to age 18 years

• Expected to require clinically indicated blood work >48 hours following study enrollment (Range: 2-7 days)

• Vitamin D deficiency, as defined by blood 25OHD < 50 nmol/L at the time of screening

Exclusion Criteria:

• Treating physician refuses enteral drug administration due to gastrointestinal disorder,

• Persistent hypercalcemia (ionized calcium >1.40 mmol/L (age >2 months), >1.45 (age <2 months) excluding transient abnormalities and those related to parenteral calcium administration for hypocalcemia;

• Confirmed or suspected William's syndrome;

• Known nephrolithiasis or nephrocalcinosis;

• Imminent plan for withdrawal of treatment or transfer to another ICU not participating in the VITdALIZE-KIDS trial;

• Physician refusal;

• Previous enrollment in this trial;

• Granulomatous disease (tuberculosis or sarcoidosis);

• Severe liver failure;

• Hypersensitivity or allergy to vitamin D or any of the non-medicinal ingredients of the formulation;

• Patient on thiazide diuretics also receiving regular ongoing calcium supplementation above the daily recommended intake;

• Adolescent female of child-bearing age with a positive pregnancy serum test;

• Patient on digoxin-therapy; and

• Treating physician intends to administer vitamin D doses above 1000 IU (e.g. patient presents with isolated clinical symptoms of severe VDD, severe burns).