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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

From: Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study)

Adverse event Study thresholds Definition Safety procedures
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