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Vitamin Supplement

Rapid Vitamin D Supplementation for Vitamin D Deficiency (VITdALIZE-KIDS Trial)

Phase 3
Recruiting
Led By Dayre McNally, MD, PhD
Research Sponsored by Children's Hospital of Eastern Ontario
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Corrected gestational age 37 weeks to age 18 years
Admitted to PICU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrolment and on >48 hours following enrollment (range: day 2-7)
Awards & highlights

VITdALIZE-KIDS Trial Summary

This trial will determine whether rapidly restoring vitamin D levels in critically ill children who are deficient improves survival and health-related quality of life.

Who is the study for?
This trial is for critically ill children in Canadian PICUs, aged from 37 weeks corrected gestational age to 18 years old, who have a confirmed vitamin D deficiency. It's not suitable for those expected to leave the PICU within three days of enrollment or with certain medical conditions like severe liver failure, hypercalcemia, or allergies to vitamin D.Check my eligibility
What is being tested?
The study tests if high-dose Vitamin D3 (cholecalciferol) can improve survival and quality of life in vitamin D deficient critically ill children compared to a placebo. Participants will receive either one dose of Vitamin D3 up to 400,000 IU or no drug and be monitored for health changes over 90 days.See study design
What are the potential side effects?
In a previous pilot trial using the same high-dose Vitamin D3 regimen, no serious side effects were reported. However, potential risks may include elevated calcium levels which could lead to kidney stones or other related issues.

VITdALIZE-KIDS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 37 weeks of corrected gestational age and 18 years old.
Select...
I am currently admitted to the Pediatric Intensive Care Unit.
Select...
I am between 37 weeks of gestation and 18 years old.
Select...
I am currently admitted to the Pediatric Intensive Care Unit.

VITdALIZE-KIDS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrolment and on >48 hours following enrollment (range: day 2-7)
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrolment and on >48 hours following enrollment (range: day 2-7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Health related quality of life
Secondary outcome measures
New and/or progressive multiple organ dysfunction
Other outcome measures
Biomarker Analysis - Anti-inflammatory cytokines
Biomarker Analysis - Bone markers
Biomarker Analysis - Brain natriuretic peptide
+11 more

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615
23%
Hypophospatemia
17%
Fatigue
13%
Increased hypertension
13%
Edema
13%
Diarrhea
13%
Pain
10%
Taste perversions
10%
Arthritis
10%
Dizziness
10%
Gastroenteritis
10%
Vertigo
10%
Rhinitis
10%
Bronchitis
10%
Rash
7%
Leg Cramps
7%
Viral Infection
7%
Hypercalcemia
7%
Allergic Infection
7%
Polydipsia
7%
Dehydration
7%
Urinary Tract Infection
3%
Chest Pain
3%
Sinusitis
3%
Headache
3%
General Infection
3%
Asthenia
3%
Fever
3%
Infection Fungal
3%
Conjuctivitis
3%
Syncope
3%
Depression
3%
Increased Cough
3%
Polyuria
3%
Abdominal Pain
3%
Photophobia
3%
Decreased libido
3%
Hypotension
3%
Nausea
3%
Esophageal ulcer
3%
Somnolence
3%
Back Pain
3%
Vomiting
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paricalcitol Treatment
Calcitriol Treatment
Cholecalciferol
Supplemental

VITdALIZE-KIDS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin DExperimental Treatment1 Intervention
Approximately half of the subjects randomized into VITdALIZE-KIDS will be randomized into the Vitamin D Group and will receive a single dose of cholecalciferol at enrolment. Participants may also receive standard vitamin D dosing at the discretion of the care team (e.g. 400-1000 IU/day).
Group II: PlaceboPlacebo Group1 Intervention
Approximately half of the subjects randomized into VITdALIZE-KIDS will be randomized into the Placebo Group and will receive a single dose of placebo at enrolment. Participants may also receive standard vitamin D dosing at the discretion of the care team (e.g. 400-1000 IU/day).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cholecalciferol
2014
Completed Phase 4
~1100

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor
125 Previous Clinical Trials
54,696 Total Patients Enrolled
2 Trials studying Vitamin D Deficiency
113 Patients Enrolled for Vitamin D Deficiency
EURO-PHARM International Canada, Inc.OTHER
1 Previous Clinical Trials
865 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,342 Total Patients Enrolled
3 Trials studying Vitamin D Deficiency
407 Patients Enrolled for Vitamin D Deficiency

Media Library

Cholecalciferol (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03742505 — Phase 3
Vitamin D Deficiency Research Study Groups: Vitamin D, Placebo
Vitamin D Deficiency Clinical Trial 2023: Cholecalciferol Highlights & Side Effects. Trial Name: NCT03742505 — Phase 3
Cholecalciferol (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03742505 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cholecalciferol been cleared by the FDA?

"Cholecalciferol has received a score of 3 for safety. This is due to being in Phase 3 clinical trials, which suggests that not only is the medication effective, but also that there is a wealth of data affirming its safety."

Answered by AI

Out of how many eligible people are being chosen to participate in this research?

"In order to run this clinical trial, 766 patients that meet the pre-determined inclusion criteria will need to enroll. Patients can choose to participate at any of the multiple locations, which include Children's Hospital of Eastern Ontario in Ottawa and Centre hospitalier universitaire Sainte-Justine in Montreal."

Answered by AI

Are there many places in North America conducting this research?

"This trial is being conducted at 9 locations in total. These sites are situated in Ottawa, Montréal, Toronto and 6 other cities. When enrolling for this study, please choose the location that is most convenient for you to reduce travel-related commitments."

Answered by AI

Are there any other ongoing research projects that explore the benefits of Cholecalciferol?

"Out of the 64 ongoing studies, 22 are in Phase 3. Most research is based in Dallas, Texas; however, there are 210 total locations running clinical trials for Cholecalciferol."

Answered by AI

For what reasons is Cholecalciferol commonly given to patients?

"Cholecalciferol can assist patients with calcium metabolism, treating fractures, and reducing the risk of spine fracture."

Answered by AI
~151 spots leftby May 2025