Please select the eligibility criteria that correspond to the clinical trial below.
Title: Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial
Brief Summary: Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory health, inflammation, innate immunity, and neuromuscular function have led to the hypothesis that deficiency might represent a modifiable risk factor for outcomes in critical illness. In recent years, dozens of adult studies have reported both high deficiency rates, and associations between lower vitamin D levels and organ dysfunction, health resource utilization, and mortality in the intensive care unit (ICU). More recently, similar observations have been made in critically ill pediatric populations. The cumulative body of basic science and clinical literature demonstrates that deficiency is common in critical illness and rapid normalization of vitamin D status could improve clinical outcomes and/or reduce health care costs. However, before conducting a phase III trial to determine whether restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing regimen must be identified. Consequently, the investigators propose a phase II, double blind randomized controlled trial to determine a loading therapy dosing regimen that can safely and rapidly normalize vitamin D status in critically ill children.


Options:
A: Inclusion Criteria:

* Newborn (corrected gestational age between 36 weeks) up to 18 years
* Has CHD that will require surgery within the next 12 months
* CHD requiring surgical intervention with cardiopulmonary bypass

Exclusion Criteria:

* Born at less than 32 weeks gestational age
* Corrected gestational age of less than 36 weeks
* Cardiac or gastrointestinal disease preventing enteral feeds or drug administration prior to surgery
* Patient has confirmed or suspected Williams syndrome
* Proposed surgery to take place at another centre (outside of CHEO)
B: Inclusion Criteria:

* Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks

Exclusion Criteria:

* Major congenital/chromosomal anomalies
* Moribund infant with low likelihood of survival, in opinion of the clinical team
C: Inclusion Criteria:

(i) Admitted to ICU; (ii) Corrected gestational age \> 37 weeks to age \< 18 years; (iii) Expected ICU admission in excess of 48 hours and expected access for blood work at Day 7 of hospital admission; (iv) Blood 25OHD less than 50 nmol/L (regardless of prior approach to supplementation)

Exclusion Criteria:

(i) Significant gastrointestinal disorder preventing enteral drug administration (e.g. necrotizing enterocolitis); (ii) Hypercalcemia (excluding transient abnormalities and those related to parenteral calcium administration for hypocalcemia); (iii) Confirmed or suspected William's syndrome; (iv) Patient known to have nephrolithiasis or Nephrocalcinosis; (v) Imminent plan for withdrawal of care or transfer to another ICU; (vi) Physician refusal; (vii) Previous enrollment in the study; (viii) Patient known to have granulomatous disease (tuberculosis or sarcoidosis), (ix) Severe liver dysfunction/liver failure; (x) Patient know to have hypersensitivity or allergy to vitamin D or any of the non-medicinal ingredients of the formulation; (xi) Patient on thiazide diuretics who is also receiving regular ongoing calcium supplementation above the daily recommended intake (for reasons other than hypocalcemia); (xii) Adolescent female of child-bearing age with a positive serum pregnancy test; or (xiii) Patient on digoxin-therapy
D: Inclusion Criteria:

* Preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound)
* In born or admitted to the unit within 48hours from birth.
* Randomization within 7 days from birth.
* Parental consent.
* Mothers willing to return for follow up visits.

Exclusion Criteria:

* Preterm delivery \>=33 weeks of gestation or term delivery (estimated by ultrasound).
* Major congenital abnormalities.
* Participation in another trial.
* Severe illness at birth deemed incompatible with survival.
* Congenital HIV infection.
* Total parenteral nutrition \> 14 days.
* Cholestasis

Answer: C