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NCT02208310 · ClinicalTrials.gov registry record · Phase 4
Trial of High Dose Vitamin D in Patient's With Crohn's Disease
A Phase 4 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT02208310: Clinical Trial Phase 4 study, sponsored by University of Michigan.
NCT02208310 is a Phase 4 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02208310, a Phase 4 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is a major source of vitamin D. There is some research to suggest that patient's with higher vitamin D levels are less likely to undergo surgeries and have better control of their disease. We intend to study the effects of high dose vitamin D supplementation in patients with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses will have less hospitalizations, surgeries, steroid use.
Primary Outcome
Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.
Interventions
- DRUG Cholecalciferol 10,000 IU
- DRUG Cholecalciferol 400 IU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 4 |
Why NCT02208310 stopped before completion
NCT02208310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Cholecalciferol 10,000 IU is the first listed.
NCT02208310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02208310 about?
NCT02208310 is a clinical study titled "Trial of High Dose Vitamin D in Patient's With Crohn's Disease". Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is a major source of vitamin D. There is some research to suggest that patient's with higher vitamin D levels are less likely to undergo surgeries and have better control of their disease. We intend to study t...
What is the current status of trial NCT02208310?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2015-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02208310?
The interventions under investigation include: Cholecalciferol 10,000 IU (DRUG), Cholecalciferol 400 IU (DRUG).
Who is sponsoring clinical trial NCT02208310?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02208310's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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