Vitamin D in Ventilated ICU Patients

Completed · Phase 2

Conditions studied: Respiratory Failure

In brief

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).

Key facts

Study ID

NCT01372995

Run by

Emory University

People needed

31

Starts

2011-07-01

Expected to finish

2014-04-01

Last updated by the study team

2017-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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