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

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)

Data category Information
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