Rapid Normalization of Vitamin D Deficiency in PICU (NCT03742505) | Clinical Trial Compass
CompletedPhase 3
Rapid Normalization of Vitamin D Deficiency in PICU
Canada424 participantsStarted 2019-06-17
Plain-language 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.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Admitted to PICU
* Corrected gestational age 37 weeks to age 18 years
* Vitamin D deficiency, as defined by blood 25OHD \< 50 nmol/L at the time of screening
Exclusion Criteria:
* Patient will be discharged from PICU before they can be enrolled (i.e. study drug administered) into the VITdALIZE-KIDS study and/or patient will be in hospital for \<3 days following enrollment
* Treating physician refuses enteral drug administration due to gastrointestinal disorder, and expects to do so for the full duration of the patient's PICU admission
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.