Phase 2
N=31
Vitamin D in Ventilated ICU Patients
Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT01372995 ↗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
| Outcome | Result | p-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.
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.