Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial
Condition: Hypovitaminosis D
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency
Intervention: Vitamin D3; Placebo
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory health,
      inflammation, innate immunity, and neuromuscular function have led to the hypothesis that
      deficiency might represent a modifiable risk factor for outcomes in critical illness. In
      recent years, dozens of adult studies have reported both high deficiency rates, and
      associations between lower vitamin D levels and organ dysfunction, health resource
      utilization, and mortality in the intensive care unit (ICU). More recently, similar
      observations have been made in critically ill pediatric populations. The cumulative body of
      basic science and clinical literature demonstrates that deficiency is common in critical
      illness and rapid normalization of vitamin D status could improve clinical outcomes and/or
      reduce health care costs. However, before conducting a phase III trial to determine whether
      restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing regimen
      must be identified. Consequently, the investigators propose a phase II, double blind
      randomized controlled trial to determine a loading therapy dosing regimen that can safely and
      rapidly normalize vitamin D status in critically ill children.
    

Eligibility criteria:

        Inclusion Criteria:

        (i) Admitted to ICU; (ii) Corrected gestational age > 37 weeks to age < 18 years; (iii)
        Expected ICU admission in excess of 48 hours and expected access for blood work at Day 7 of
        hospital admission; (iv) Blood 25OHD less than 50 nmol/L (regardless of prior approach to
        supplementation)

        Exclusion Criteria:

        (i) Significant gastrointestinal disorder preventing enteral drug administration (e.g.
        necrotizing enterocolitis); (ii) Hypercalcemia (excluding transient abnormalities and those
        related to parenteral calcium administration for hypocalcemia); (iii) Confirmed or
        suspected William's syndrome; (iv) Patient known to have nephrolithiasis or
        Nephrocalcinosis; (v) Imminent plan for withdrawal of care or transfer to another ICU; (vi)
        Physician refusal; (vii) Previous enrollment in the study; (viii) Patient known to have
        granulomatous disease (tuberculosis or sarcoidosis), (ix) Severe liver dysfunction/liver
        failure; (x) Patient know to have hypersensitivity or allergy to vitamin D or any of the
        non-medicinal ingredients of the formulation; (xi) Patient on thiazide diuretics who is
        also receiving regular ongoing calcium supplementation above the daily recommended intake
        (for reasons other than hypocalcemia); (xii) Adolescent female of child-bearing age with a
        positive serum pregnancy test; or (xiii) Patient on digoxin-therapy