Vitamin D in Ventilated ICU Patients
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Intervention: Enteral Vitamin D3 50,000 IU; Enteral Vitamin D3 100,000IU; Inactive substance
Intervention description: 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.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: critical care; nosocomial infection; antiAntimicrobial peptide expression; LL-37; hBD-2; cathelicidin; microbial peptide

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.