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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). 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.
Primary Outcome
Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Vitamin D status at the onset of a suspected case of sepsis will be compared to vitamin D status between 5-9 days after supplementation with cholecalciferol or placebo. To assess vitamin D status, we will measure serum and urine: 1) 25-hydroxyvitamin D; 2) 1,25-dihydroxyvitamin D; 3) 24,25-dihydroxyvitamin D; 4) Fibrobl
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 |
What the finished NCT01896544 record still lists
NCT01896544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Cholecalciferol is the first listed.
NCT01896544 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01896544's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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