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NCT01465113 · ClinicalTrials.gov registry record · Early Phase 1
Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus
A Early Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
NCT01465113: Completed Early Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT01465113 is a Early Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 26 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01465113, a Early Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study is being conducted to determine if vitamin D supplementation increases the level of a protein that may be involved in decreasing the risk of esophageal cancer in patients with Barrett's esophagus. Subjects with Barrett's esophagus will take vitamin D supplementation for 2-12 weeks depending on the severity of their condition, and receive an upper endoscopy procedure before and after vitamin D supplementation trial.
Primary Outcome
To determine whether vitamin D supplementation induces 15-Prostaglandin dehydrogenase expression as measured by RT-PCR in Barrett's esophagus
Interventions
- DRUG Metformin
- DRUG Omeprazole
- DRUG Vitamin D3
- PROCEDURE upper endoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-05 |
| Est. Completion | 2016-02 |
| Phase | Early Phase 1 |
What the finished NCT01465113 record still lists
NCT01465113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT01465113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01465113 about?
NCT01465113 is a clinical study titled "Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus". This study is being conducted to determine if vitamin D supplementation increases the level of a protein that may be involved in decreasing the risk of esophageal cancer in patients with Barrett's esophagus. Subjects with Barrett's esophagus will take vitamin D supplementation for 2-12 weeks dependi...
What is the current status of trial NCT01465113?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2010-05. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01465113?
The interventions under investigation include: Metformin (DRUG), Omeprazole (DRUG), Vitamin D3 (DRUG), upper endoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT01465113?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01465113's enrollment target sits among peer trials
26 977th of 2000 higher than 1,001 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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