Critically ill children with severe vitamin D deficiency MedDRA version: 19.1 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Oleovit
Pharmaceutical Form: Oral liquid
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: Colecalciferol concentrate (oily form)
Concentration unit: IU/ml international unit(s)/
Sponsors
Children's Hospital of Eastern Ontario
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria for this study are: Admitted to ICU, Corrected gestational age > 37 weeks to age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded: Significant gastrointestinal disorder preventing enteral drug administration (e.g. necrotizing enterocolitis); Hypercalcemia (excluding transient abnormalities and those related to parenteral calcium administration for hypocalcemia); Confirmed or suspected William’s syndrome; Patient known to have 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 granulomatous disease (tuberculosis or sarcoidosis), Severe liver dysfunction/liver failure; Patient know to have hypersensitivity or allergy to vitamin D or any of the non-medicinal ingredients of the formulation;Patient on thiazide diuretics who is also receiving regular ongoing calcium supplementation above the daily recommended intake for reasons other than hypocalcemia; Adolescent female of child-bearing age with a positive serum pregnancy test; or Patient on digoxin-therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether a weight based enteral loading dose protocol can rapidly normalize vitamin D levels in critically ill children;Secondary Objective: To evaluate whether the weight based vitamin D loading protocol, when compared with usual care, results in: 1. Greater occurrence of vitamin D related adverse events (e.g. hypercalcemia, hypercalciuria) 2. Improved vitamin D axis functioning (e.g. active hormone levels, calcium metabolism) 3. Differences in blood measures of inflammation and innate immunity (e.g. CRP, procalcitonin;Primary end point(s): To determine whether loading dose therapy can rapidly normalize vitamin D status we will measure blood 25(OH)D concentration. More specifically, our primary outcome is the proportion of critically ill children who achieve blood 25(OH)D concentration above 75 nmol/L by day 7. 25(OH)D is widely regarded as the best indicator of vitamin D status;Timepoint(s) of evaluation of this end point: up to 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Vitamin D related adverse events Hypercalcemia – We will define hypercalcemia as an ionized calcium level above 1.40 mmol/L (children under 8 weeks as > 1.45 mmol/L) Hypercalcuria – We will identify hypercalcuria using calcium-creatinine ratios, defined using age specific norms and thresholds;Timepoint(s) of evaluation of this end point: up to 2 years | — |
Countries
Austria, Canada, Chile
Contacts
Public ContactDivision of Endocrinology and D.
Medical University of Graz
Outcome results
None listed