At a glance
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High-Dose Vitamin D and Antimicrobial Peptide Expression in Lung Failure
In Brief
A Phase 2 clinical trial evaluating Enteral Vitamin D3 50,000 IU, Enteral Vitamin D3 100,000IU, and 1 other intervention for Respiratory Failure. Completed, enrolled 31 participants across 2 sites.
Detailed Summary
The increasing rate of hospital-acquired infection and antibiotic resistance are major causes of prolonged ICU stay and death in hospitalized patients. The enormous impact of ICU-related infection demands the need for cost-effective therapies that can be rapidly implemented to improve patient immune response to control infection. Unfortunately, little high-quality comparative effectiveness research has been performed on micronutrient treatment regimens as methods to decrease hospital-acquired infection in critically ill patients. Critically ill medical and surgical patients have an extremely high prevalence of vitamin D insufficiency. We will perform a rigorous, double-blind, randomized, controlled, pilot clinical trial in ventilator-dependent ICU patients to test the clinical/metabolic safety and efficacy of two doses of oral high-dose vitamin D3 therapy versus standard therapy (no supplemental vitamin D). The primary endpoint is to test whether high-dose regimens \[either 50,000 or 100,000 international units (IU) of enteral vitamin D3 given daily for 5 consecutive days (total dose = 250,000 or 500,000 IU, respectively) increase plasma 25(OH)D concentrations into a desirable range (\> 30 ng/mL).
Study Details
Timeline
Interventions
Enteral Vitamin D3 50,000IU x 5 days (total dose 250,000IU)
Enteral Vitamin D3 100,000IU over 5 days (total 500,000IU)
Inactive substance given enterally for 5 days.