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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01759771
The ClinicalTrials.gov registry entry for NCT01759771 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01759771 reports 0 study locations.
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.
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