This group will receive daily cholecalciferol (vitamin D3) based on the Adequate Intake (AI) for infants and the Recommended Dietary Allowance (RDA) for children over 1 year. Specific dose amounts are 400 IU per day for infants (0-1 year), and 600 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a placebo solution.

This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.

Usual Care Group

This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.
Cholecalciferol: The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)

High Dose Group

Total

Sex: Female, Male

Weight (kg)

The Risk Adjustment in Congenital Heart Surgery (RACHS) allows a detailed understanding of differences in mortality among pediatric patients who are undergoing surgery for congenital heart disease (CHD). Patients are assigned to to one of 6 risk categories (Risk Category 1 to Risk Category 6) based on the type of cardiac procedures. The risk categories group cardiac procedures with similar risks for in-hospital death together. A higher risk category means a higher risk of in-hospital death.

RACHS Score

Other active medical condition

Surgery season

Ethnicity

Expected Duration to Surgery at Time of Enrolment

Type of Feeding in Children <1 year

Blood 25OHD will be measured to determine vitamin D deficiency, with a concentration below 50 nmol/L used to define deficiency. A PICU admission blood sample could not be obtained for one patient in the Usual Care Group and one patient in the High Dose Group, thus the total number analyzed differs from the full sample size.

Blood 25 Hydroxyvitamin D (25OHD) Concentrations

Hypercalcemia will be defined as an ionized calcium level above 1.40 mmol/L; or above 1.45 mmol/L for children under 8 weeks. Hypercalcemia will be evaluated in blood collected immediately before CHD surgery and throughout the post-operative course (measurements are standard of care).

Number of Participants With Hypercalcemia as a Vitamin D Related Adverse Event

Hypercalciuria will be identified using calcium:creatinine ratios defined using age-specific norms and thresholds.

Number of Participants With Hypercalciuria

Impaired vitamin D axis function will be defined as an inability to restore and maintain active hormone levels in the normal range following surgery after the first post-operative day

Vitamin D Parathyroid Renal Axis Function Through Changes in Blood 1,25-dihydroxycholecalciferol

Changes in Cathelicidin as Measure of Innate Immune Function

Primarily, post-operative catecholamine requirements during the PICU admission will be evaluated as a dichotomous variable (yes/no). If a difference is noted in the primary analysis, inotrope requirements will be determined using the inotrope score, evaluated as the maximum score and in a time to event approach (off all inotropes, score of zero)

Post-operative PICU Catecholamine Requirements

The post-operative day 1 echocardiogram will be used to evaluate for differences in cardiovascular function between study arms.

Cardiovascular Function Through an Echocardiogram

Overall Study

Katie O'Hearn, PICU Research Coordinator

Vitamin D Deficiency

Thoracic Surgery

Pediatric Disorders

Heart Defects, Congenital

The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)

Cholecalciferol

Children's Hospital of Eastern Ontario

Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level

Prevention of Post-Cardiac Surgery Vitamin D Deficiency in Children With Congenital Heart Disease: A Pilot Dose Evaluation Randomized Controlled Trial

James Dayre McNally

Dr. James Dayre McNally, Pediatric Intensivist, Department of Pediatrics, CHEO, Associate Investigator, CHEO Research Institute

The Ottawa Hospital

McGill University

Children's University Hospital, Ireland

Ottawa Hospital Research Institute

Oral cholecalciferol (100,000 IU) administered orally every 60 days plus calcium carbonate (1 gram)given daily

HIV Infection

Bone Mass

oral calciferol 100,000 IU by mouth bimonthly and calcium carbonate (1 gr) by mouth daily

hypercalciuria/karies

Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level

The Effect of Vitamin D and Calcium on Bone in Pediatric HIV

Dose-Dependent Effect of Thiazide in Dent's Disease Hypercalciuria

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