Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans

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.

Conditions

• Prostate Cancer
• Vitamin D Deficiency
• Stress Reaction

Interventions

DRUG

cholecalciferol

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

PROCEDURE

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

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

PROCEDURE

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

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%).

DIAGNOSTIC_TEST

Allostatic Load

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

Sponsors & Collaborators

• Ralph H. Johnson VA Medical Center

  collaborator FED

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Chanita Hughes-Halbert, PhD · MUSC Psychiatry and Behavioral Sciences

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-04

Primary Completion

2022-02-04

Completion

2022-02-04

FDA Drug

Yes

Countries

• United States

Study Locations