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Rapid Vitamin D Supplementation for Vitamin D Deficiency (VITdALIZE-KIDS Trial)
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.
VITdALIZE-KIDS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVITdALIZE-KIDS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2010 Phase 4 trial • 109 Patients • NCT01265615VITdALIZE-KIDS Trial Design
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Who is running the clinical trial?
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- I am between 37 weeks of corrected gestational age and 18 years old.I have severe liver failure.I am currently admitted to the Pediatric Intensive Care Unit.My doctor has advised against me joining this trial.I have been diagnosed with kidney stones or kidney calcification.I have been diagnosed with or suspected to have William's syndrome.My doctor plans to give me high doses of vitamin D.I am not planning to stop or change my current treatment for another ICU not in the VITdALIZE-KIDS trial.I am a young woman who can have children and I am pregnant.I am between 37 weeks of gestation and 18 years old.I am currently taking digoxin.I will leave the intensive care unit before joining the study or will stay in the hospital for less than 3 days after joining.I am taking more calcium than recommended while on water pills.My doctor won't give me drugs by mouth due to a stomach issue for my entire PICU stay.I have been diagnosed with tuberculosis or sarcoidosis.I am currently admitted to the Pediatric Intensive Care Unit.
- Group 1: Vitamin D
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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