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NCT03096314 · ClinicalTrials.gov registry record · Phase 3
Vitamin D to Improve Outcomes by Leveraging Early Treatment
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,358
- Enrollment target
NCT03096314: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT03096314 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 1,358 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03096314, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,358 participants
- Enrollment target
Study Summary
Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D3 supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Patients screened as vitamin D deficient (\<20 ng/mL) were randomized. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D3 or matched placebo. The primary end point was 90-day all-cause, all-location mortality.
Interventions
- DRUG Placebo
- DRUG Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,358 participants |
| Start Date | 2017-04-27 |
| Est. Completion | 2018-12-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03096314
The ClinicalTrials.gov registry entry for NCT03096314 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,358 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 Placebo is the first listed.
NCT03096314 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03096314 about?
NCT03096314 is a clinical study titled "Vitamin D to Improve Outcomes by Leveraging Early Treatment". Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D3 supplementation in critically ill, vitamin D-deficient patients who were at hi...
What is the current status of trial NCT03096314?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,358 participants. The study started on 2017-04-27. Estimated completion is 2018-12-11.
What interventions are being tested in trial NCT03096314?
The interventions under investigation include: Placebo (DRUG), Vitamin D3 (DRUG).
Who is sponsoring clinical trial NCT03096314?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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