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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, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% higher). 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.
Primary Outcome
Vital status of the patient at day 90 was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, review of obituaries, or information from the Centers for Disease Control and Prevention's National Death Index (NDI).
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 |
What the finished NCT03096314 record still lists
NCT03096314 is an interventional study that assigns participants to a tested intervention. Its 1,358 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03096314 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03096314's enrollment target sits among peer trials
1,358 180th of 2000 higher than 1,820 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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