A phase II dose evaluation pilot feasibility randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study)

Table 4 Assessment of Phase III trial feasibility

Feasibility Criteria		Outcome	Feasibility Criteria Met
Study Withdrawal	Withdrawal rate of < 10% of enrolled patients will be considered successful	One patient was randomized but withdrawn prior to study drug administration due to withdrawal of assent	Yes
Patient Accrual	An accrual rate of 67 patients within 2 years (average 2.8 patients/month) will be considered successful	67 patients enrolled over a 20-month period (average 3.4 patients/month). This is equivalent to 1.9 patients/site/month	Yes
Ability to Maintain Blinding	Care team or pharmacy request for unblinding in < 10% of enrolled patients will be considered successful	Blinding was broken for one study patient (1% of enrolled patients) at the request of the principal investigator. No patients were unblinded at the request of pharmacy or the clinical team	Yes
Eligibility Criteria^a	Ability to obtain a blood sample in 95% of enrolled patients will be considered successful	A Day 7 blood sample was collected for 56 patients (84% of enrolled patients)	No
Protocol Adherence	Occurrence of major protocol deviations with regard to study drug administration or safety procedures in < 20% of enrolled patients will be considered successful	No deviations related to study drug administration or safety procedures	Yes

^aEligibility criteria was evaluated based on our ability to predict ICU stay longer than 48 h and bloodwork access at 7 days for collection of blood sample at Day 7

ISSN: 1471-2431