CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
cholecalciferol +1 moredrug
Likely dose
cholecalciferol 4000 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/NCT02726113
NCT02726113Phase 2Completed

Vitamin D and Prostate Cancer: A Randomized Clinical Study

Medical University of South Carolina·interventional·Posted Apr 1, 2016·Updated Dec 3, 2019

In Brief

A Phase 2 clinical trial evaluating cholecalciferol and placebo for Prostate Cancer. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

The study population will be 80 adult men who have been diagnosed with prostate cancer who are scheduled to have their prostate surgically removed at either the Medical University of South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men will be randomized into two groups: one group will take vitamin D3 supplementation and the other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of the study and again after two months, just prior to the surgical procedure (prostatectomy). Prostate tissue will be obtained from the surgical procedure and studied for the effect of vitamin D on the prostate cancer cells.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2016
Enrollment StartOct 1, 2011
Primary CompletionMar 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.3 years ago

Interventions

cholecalciferoldrug

softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy).

placeboother

softgel containing no active ingredient daily for approximately two months prior to surgery (prostatectomy).