Rapid normalization of Vitamin D in critically ill childre

Phase 1

• Conditions: Critically ill children with severe vitamin D deficiency; MedDRA version: 19.1Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-002459-38-AT
• Lead Sponsor: Children's Hospital of Eastern Ontario

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-19
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

The inclusion criteria for this study are:
Admitted to ICU,
Corrected gestational age > 37 weeks to age < 18 years,
Expected ICU admission in excess of 48 hours, and will have access for bloodwork at 7 days (clinical bloodwork or lines)
Blood 25(OH)D less than 50 nmol/L (regardless of prior approach to supplementation),
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>1. Greater occurrence of vitamin D related adverse events (e.g. hypercalcemia, hypercalciuria)<br>2. Improved vitamin D axis functioning (e.g. active hormone levels, calcium metabolism)<br>3. Differences in blood measures of inflammation and innate immunity (e.g. CRP, procalcitonin;Timepoint(s) of evaluation of this end point: up to 2 years;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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Vitamin D related adverse events <br>Hypercalcemia – We will define hypercalcemia as an ionized calcium level above 1.40 mmol/L (children under 8 weeks as > 1.45 mmol/L)<br>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