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NCT01372995 · ClinicalTrials.gov registry record · Phase 2
Vitamin D in Ventilated ICU Patients
A Phase 2 study of Respiratory Failure, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 2
- Study locations
NCT01372995: Completed Phase 2 study of Respiratory Failure, sponsored by Emory University.
NCT01372995 is a Phase 2 study of Respiratory Failure that has completed, run by Emory University. The registered enrollment target is 31 participants, below the 4,523-participant average among 40 other Respiratory Failure trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01372995, a Phase 2 study of Respiratory Failure, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement.
Conditions Studied
Interventions
- DRUG Enteral Vitamin D3 50,000 IU
- DRUG Enteral Vitamin D3 100,000IU
- OTHER Inactive substance
Study Locations (2)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01372995 record still lists
NCT01372995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 4,523-participant average among 40 other Respiratory Failure trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Respiratory Failure appearing as the primary indexed condition, and to 3 interventions - of which Enteral Vitamin D3 50,000 IU is the first listed.
NCT01372995 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01372995 about?
NCT01372995 is a clinical study titled "Vitamin D in Ventilated ICU Patients". 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...
What is the current status of trial NCT01372995?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2011-07. Estimated completion is 2014-04.
What conditions does trial NCT01372995 study?
This clinical trial studies the following conditions: Respiratory Failure.
What interventions are being tested in trial NCT01372995?
The interventions under investigation include: Enteral Vitamin D3 50,000 IU (DRUG), Enteral Vitamin D3 100,000IU (DRUG), Inactive substance (OTHER).
Who is sponsoring clinical trial NCT01372995?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01372995 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01372995's enrollment target sits among peer trials
31 32nd of 40 higher than 9 of 40 other Respiratory Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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