Phase 2 Completed N=67 Randomized Quadruple-blind Treatment

Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial

Hypovitaminosis D

Source: ClinicalTrials.gov NCT02452762 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcomePrimary: Vitamin D Status — 81.6; 5.6 Percentage of participants in study arm

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Vitamin D Status	81.6; 5.6	—
SECONDARY Patient Accrual Rate	3.35	—
SECONDARY Vitamin D Related Adverse Events	0; 0; 6; 4; 34; 15	—
SECONDARY Vitamin D Axis Function - Calcium	1.17; 1.18; 1.22; 1.21; 1.16; 1.12	—
SECONDARY Vitamin D Axis Function - 1,25-dihydroxyvitamin D	—	—
SECONDARY Immune Function - Cathelicidin	—	—

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

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Data sourced from ClinicalTrials.gov (NCT02452762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.