CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Vitamin D3 +1 moredrug
Likely dose
Vitamin D3 4,000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01759771
NCT01759771Phase 2Completed
CompareCT.gov

Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial

VA Office of Research and Development·interventional·Posted Jan 3, 2013·Updated Mar 18, 2024

In Brief

A Phase 2 clinical trial evaluating Vitamin D3 and Placebo for Prostate Cancer. Completed, enrolled 130 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsMedical University of South Carolina

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 3, 2013
Enrollment StartJan 3, 2013
Primary CompletionOct 18, 2018
Study CompletionMay 11, 2020
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 13.5 years ago

Interventions

Vitamin D3drug

4,000 IU of VD3 for at least one year

Placebodrug

Placebo for at least one year