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NCT01689441 · ClinicalTrials.gov registry record · Phase 2
Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
A Phase 2 study of Severe Sepsis or Septic Shock, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT01689441: Completed Phase 2 study of Severe Sepsis or Septic Shock, sponsored by Brigham and Women's Hospital.
NCT01689441 is a Phase 2 study of Severe Sepsis or Septic Shock that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01689441, a Phase 2 study of Severe Sepsis or Septic Shock, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Calcitriol
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
What the finished NCT01689441 record still lists
NCT01689441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Severe Sepsis or Septic Shock appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01689441 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01689441 about?
NCT01689441 is a clinical study titled "Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis". Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is sim...
What is the current status of trial NCT01689441?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2013-02. Estimated completion is 2014-02.
What conditions does trial NCT01689441 study?
This clinical trial studies the following conditions: Severe Sepsis or Septic Shock.
What interventions are being tested in trial NCT01689441?
The interventions under investigation include: Placebo (DRUG), Calcitriol (DRUG).
Who is sponsoring clinical trial NCT01689441?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01689441 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01689441's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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