CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 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/NCT00953225
NCT00953225Phase 2Completed

Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer

VA Office of Research and Development·interventional·Posted Aug 6, 2009·Updated Oct 9, 2017

In Brief

A Phase 2 clinical trial evaluating vitamin D3 and Placebo daily for one year for Prostate Cancer. Completed, enrolled 83 participants across 2 sites.

Detailed Summary

Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical prostate cancer to clinical disease. The investigators propose to conduct a clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease monitored through active surveillance. The successful completion of this proposed clinical study will allow us to determine whether correcting vitamin D deficiency in Veterans diagnosed with early-stage prostate cancer will prevent progression of their disease and improve their prognosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartJan 7, 2010
Primary CompletionDec 15, 2013
Study CompletionOct 30, 2014
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 16.9 years ago

Interventions

vitamin D3drug

4,000 IU daily for one year

Placebo daily for one yeardrug

Placebo