CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
cholecalciferol +3 moredrug
Likely dose
cholecalciferol 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/NCT04621500
NCT04621500Phase 2Completed
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Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans

Medical University of South Carolina·interventional·Posted Nov 9, 2020·Updated Jul 4, 2025

In Brief

A Phase 2 clinical trial evaluating cholecalciferol, Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq, and 2 other interventions for Prostate Cancer and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Veterans between the ages of 50-75, who are having a prostate biopsy, will be recruited for their permission to collect an extra biopsy core for RNA-sequencing. If the participants' treatment decision is Active Surveillance, they will be enrolled into the intervention phase of the study. They will receive supplementation with Vitamin D3 (4,000 IU) daily with repeat (surveillance) prostate biopsy one year later. At that time an extra prostate sample core will be collected for RNA-sequencing to determine changes over time. Measurements for allostatic load (body stress/inflammatory markers) will also be collected at the time of enrollment and at the repeat prostate biopsy visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Vitamin D Deficiency, Stress Reaction
CountriesUnited States
CollaboratorsRalph H. Johnson VA Medical Center, National Institute on Minority Health and Health Disparities (NIMHD)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 9, 2020
Enrollment StartJun 4, 2019
Primary CompletionFeb 4, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.6 years ago

Interventions

cholecalciferoldrug

Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year

Standard of Care Prostate Biopsy - collection of 13th core for RNA-seqprocedure

RNA-seq analysis will be used to (a) identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men and (b) compare Allostatic Load results to determine stress response and (c) identify changes in the molecular signature in relation to vitamin D levels

Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementationprocedure

Pathology results of the prostate biopsies will be analyzed for changes in the (a) Gleason Score (b) the number of positive cores (0 to 12) and (c) the highest percentage of positive core involvement (0 to 100%).

Allostatic Loadother

Diagnostic Test: Allostatic Load Measurements at baseline and after one year vitamin D3 supplementation Allostatic Load measurements to determine body stress compared at baseline and after one year of vitamin D3 supplementation. Also compared with RNA-seq results to determine stress response. Other Names: Bloodwork for HgbA1c, lipid profile, creatinine, albumin and vitamin D levels. Body measurements: Ht. Wt, BMI, waist and hip measurements for waist/hip ratio. Measurements of systolic and diastolic blood pressure and heart rate