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Phase 2 N=31 Randomized Quadruple-blind Treatment

Vitamin D in Ventilated ICU Patients

Respiratory Failure

Enrolled (actual)
31
Serious AEs
13.3%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline — 2; 2; 1 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Enteral Vitamin D3 50,000 IU (Drug); Enteral Vitamin D3 100,000IU (Drug); Inactive substance (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Emory University
Primary completion
Apr 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline
2; 2; 1
PRIMARY
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7
2; 4; 9
PRIMARY
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14
2; 5; 5
PRIMARY
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21
1; 3; 2
PRIMARY
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28
0; 2; 1
PRIMARY
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84
1; 0; 0
SECONDARY
Change in Plasma LL-37 Levels
-3.8; 6.0; -13.5; 1.1; -12.3; -6.0
SECONDARY
Duration of Time on Ventilator
20; 12; 14
SECONDARY
Duration of Time in Intensive Care Unit (ICU)
23; 17; 15
SECONDARY
Duration of Time in Hospital
36; 25; 18
SECONDARY
Change in Sequential Organ Failure Assessment (SOFA) Score
-2; -3; -2
SECONDARY
Number of Hospital Acquired Infections
3; 3; 2
SECONDARY
Number of Hospital Mortality Cases
1; 0; 1
SECONDARY
Day 84 Mortality
2; 1; 4

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).

Eligibility Criteria

Inclusion Criteria

  • Receiving care in an intensive care unit (ICU)
  • Age greater than 18 years
  • Expected to require mechanical ventilation for at least 72 hours after entry
  • Expected to survive and remain in the ICU for at least 96 hours after study entry
  • To enable delivery of study drug, the subject has enteral access in place and is deemed able to tolerate enteral drug administration

Exclusion Criteria

  • Inability to obtain or declined informed consent from the subject and/or legally authorized representative
  • Pregnancy
  • Ongoing shock
  • Current hypercalcemia (albumin-corrected serum calcium > 10.8 mg/dL or ionized calcium > 5.2 mg/dL)
  • History of therapy with high-dose vitamin D to treat vitamin D deficiency within previous 6 months
  • History of disorders associated with hypercalcemia; history of cancer with history of hypercalcemia within the past 1 year, hyperparathyroidism, sarcoidosis, nephrolithiasis]
  • Chronic renal dysfunction requiring chronic dialysis
  • Known history of cirrhosis
  • History of AIDS
  • The patient has received any investigational drug within 60 days prior to study entry.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01372995). 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.

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