Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT03742505
Eligibility Criteria:
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 vitamin D doses above 1000 IU (e.g. patient presents with isolated clinical symptoms of severe VDD, severe burns).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT03742505
Study Brief:
Protocol Section:
NCT03742505