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NCT01896544 · ClinicalTrials.gov registry record · Phase 3
Cholecalciferol Supplementation for Sepsis in the ICU
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT01896544: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT01896544 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01896544, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
Sepsis in a clinical entity that occurs in patients with serious infections. Though the severity of illness may vary, every year, approximately 1.6 million Americans are treated for sepsis. Even with timely interventions, anywhere from 16% to \>80% of patients with sepsis will not survive. Immune dysfunction is thought to play a critical role in the ability for infections to evolve into sepsis and to eventually lead to death. Recently, vitamin D has been identified as a key regulator of the immune system. While it remains unclear whether optimizing vitamin D status may improve outcomes in sepsis, little is known about the effects of vitamin D supplementation in patients with severe infections. As such, our goal is to study whether high doses of cholecalciferol (vitamin D3) can improve vitamin D status and boost certain aspects of the immune system in patients with sepsis.
Interventions
- DIETARY_SUPPLEMENT Cholecalciferol
- DIETARY_SUPPLEMENT Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01896544
The ClinicalTrials.gov registry entry for NCT01896544 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cholecalciferol is the first listed.
NCT01896544 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01896544 about?
NCT01896544 is a clinical study titled "Cholecalciferol Supplementation for Sepsis in the ICU". Sepsis in a clinical entity that occurs in patients with serious infections. Though the severity of illness may vary, every year, approximately 1.6 million Americans are treated for sepsis. Even with timely interventions, anywhere from 16% to \>80% of patients with sepsis will not survive. Immune dy...
What is the current status of trial NCT01896544?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2014-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01896544?
The interventions under investigation include: Cholecalciferol (DIETARY_SUPPLEMENT), Placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01896544?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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