Table 1 World Health Organization trial registration data set––structured summary

Primary registry, trial identifying #

Clinicaltrials.gov identifier-NCT02452762

Date of registration in primary registry

March 15, 2015

Secondary identifying numbers

Health Canada control number and protocol title #184825, VITdAL-PICU-01; Children’s Hospital of Eastern Ontario REB number 15/18E

Sources of monetary support

AHSC Innovation Fund at the Children’s Hospital of Eastern Ontario, Canadian Health Research Institutes Project Scheme Grant

Primary sponsor

Investigator initiated: James Dayre McNally

Children’s Hospital of Eastern Ontario

401 Smyth Road

Ottawa, Ontario

K1H 8L1

Phone: 613-737-7600 ext. 3553

Email: dmcnally@cheo.on.ca

Secondary sponsor

Children’s Hospital of Eastern Ontario Research Institute

Contact for public queries

JDM, Pediatric Critical Care, Children’s Hospital of Eastern Ontario, Canada

Contact for scientific queries

JDM, Pediatric Critical Care, Children’s Hospital of Eastern Ontario, Canada

Public title

Rapid normalization of vitamin D in critically ill children: a phase II dose evaluation randomized controlled trial (VITdAL-PICU)

Scientific title

Rapid normalization of vitamin D in critically ill children: a phase II dose evaluation randomized controlled trial

Country of recruitment

Canada, Chile, Austria

Health problem under investigation

Vitamin D deficiency in critically ill children

Key inclusion and exclusion criteria

Inclusion criteria: admitted to ICU, corrected gestational age > 37 weeks and < 18 years, expected ICU admission in excess of 48 h and expected to have access for bloodwork at day 7, blood 250HD < 50 nmol/L

Exclusion criteria: significant gastrointestinal disorder preventing enteral drug administration, hypercalcemia, confirmed or suspected William’s syndrome, nephrolithiasis or nephrocalcinosis, imminent plan for withdrawal of care or transfer to another ICU, physician refusal, previous enrollment in the study, patient known to have Granulomatus disease, severe liver dysfunction/liver failure, hypersensitivity or allergy to vitamin D or any of the non-medical ingredients in the formulation, patient on thiazide diuretics who is also receiving regular ongoing calcium supplementation, pregnancy, digoxin-therapy

Study type

Randomized, double-blind phase II dose evaluation trial

Date of first enrollment

29 January 2016

Target sample size

67

Recruitment status

Recruitment initiated on 11 January 2016; recruitment ongoing

Primary outcome

To determine whether a weight-based enteral dosing protocol can rapidly normalize vitamin D status in critically ill deficient children