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NCT01574027 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Vitamin D in Colorectal Cancer Chemoprevention
A Phase 2 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT01574027: Completed Phase 2 study, sponsored by University of Illinois at Chicago.
NCT01574027 is a Phase 2 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01574027, a Phase 2 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The biologically active version of vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause serum calcium levels to rise. In contrast, 25(OH)D3 (ie calcifediol) does not have this side effect. The investigators previous research suggests that the enzyme necessary to convert 25(OH)D3 (calcifediol) into active 1,25(OH)D3 is present in cells lining the large intestine (colon). Aberrant crypt foci (ACF) are very small (ie microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases. The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number.
Primary Outcome
The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number.
Interventions
- DRUG Placebo
- DRUG Vitamin D3 (cholecalciferol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT01574027 record still lists
NCT01574027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01574027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01574027 about?
NCT01574027 is a clinical study titled "Efficacy of Vitamin D in Colorectal Cancer Chemoprevention". Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The biologically active version of vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause serum calcium levels to rise. In ...
What is the current status of trial NCT01574027?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2008-04. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01574027?
The interventions under investigation include: Placebo (DRUG), Vitamin D3 (cholecalciferol) (DRUG).
Who is sponsoring clinical trial NCT01574027?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01574027's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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