Table 4 Definition of vitamin D-related adverse events monitored in real-time through lab values from the clinical laboratory and safety procedures for elevated lab values in the VITdAL-PICU pilot study

Hypercalcemia

Ionized calcium level:

> 1.40 mmol/L

> 1.45 mmol/L for children < 8 weeks of age

Persistent hypercalcemia for > 24 h in the absence of calcium administration

Endocrinology consult, managed clinically as determined by endocrinology

Hypercalciuria (calcium:creatinine ratio)

Age-based thresholds:

< 1 2.2 mol/mol

1–2 1.5 mol/mol

2–3 1.4 mol/mol

3–5 1.1 mol/mol

5–7 0.8 mol/mol

7–17 0.7 mol/mol

Hypercalciuria, as determined by a calcium:creatinine ratio above the study threshold in two sequential urine samples (excluding enrolment sample)

Nephrology consult, case reviewed to determine the need for repeat urine sample, abdominal ultrasound, and/or clinical management by nephrology

Hypervitaminosis D

25(OH)D > 200 nmol/L

25(OH)D level > 200 nmol/L in day 7 sample

Endocrinology consult, managed clinically as determined by endocrinology