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NCT01759771 · ClinicalTrials.gov registry record · Phase 2
Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT01759771: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT01759771 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01759771, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
Vitamin D promotes the differentiation of prostate cancer cells and maintains the differentiated phenotype of prostate epithelial cells. The results of the investigators' clinical studies indicate that vitamin 1,25 dihydroxyvitamin D3 (VD3) supplementation results in a decrease of positive cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators hypothesize that Veterans who have early-stage prostate cancer and who take vitamin D3 at 4000 international units per day (intervention group) will show an improvement in the number of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of undergoing definitive treatment (prostatectomy or radiation therapy), compared to Veteran subjects taking placebo (control group).
Primary Outcome
pathology status will be measured by the number of positive cores in prostate needle biopsy specimens between baseline and the repeat standard of care prostate biopsy at the end of the study.
Interventions
- DRUG Placebo
- DRUG Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2013-01-03 |
| Est. Completion | 2020-05-11 |
| Phase | Phase 2 |
What the finished NCT01759771 record still lists
NCT01759771 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01759771 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01759771 about?
NCT01759771 is a clinical study titled "Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial". Vitamin D promotes the differentiation of prostate cancer cells and maintains the differentiated phenotype of prostate epithelial cells. The results of the investigators' clinical studies indicate that vitamin 1,25 dihydroxyvitamin D3 (VD3) supplementation results in a decrease of positive cancer co...
What is the current status of trial NCT01759771?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2013-01-03. Estimated completion is 2020-05-11.
What interventions are being tested in trial NCT01759771?
The interventions under investigation include: Placebo (DRUG), Vitamin D3 (DRUG).
Who is sponsoring clinical trial NCT01759771?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01759771's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 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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