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

NCT04621500 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 000851405U54MD010706-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation.

  RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.

  Scheduled prostate biopsy at baseline and repeat biopsy after 1 year

Secondary Outcomes (2)

• Median Percentage of Positive Cores at 1-year Post-baseline

  Scheduled prostate biopsy at baseline and repeat biopsy after 1 year

• Identify Changes in Molecular Signature That Exist in AA and Caucasian Men in Relation to Vitamin D Levels

  Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits

Study Arms (1)

Open label

OTHER

All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.

Drug: cholecalciferol; Procedure: Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq; Procedure: Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation; Diagnostic Test: Allostatic Load

Interventions

cholecalciferol DRUG

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

Also known as: vitamin D3

Open label

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

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

Open label

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

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%).

Open label

Allostatic Load DIAGNOSTIC_TEST

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

Open label

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Individuals having a prostate biopsy are eligible for recruitment.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recruitment:
• scheduled for prostate biopsy
• permission for investigators to follow subject's post biopsy diagnosis, treatment decision and follow-up care (including subsequent prostate biopsies).
• Enrollment:
• diagnosis of prostate cancer
• treatment recommendation or subject decision of Active Surveillance
• agreement to supplement with vitamin D3 4,000 IU daily for approximately one year
• standard of care repeat PSA at six months and surveillance prostate biopsy at one year

You may not qualify if:

• current vitamin D3 supplementation \> 2,000 IU daily
• inability or unwillingness to continue to participate in the study

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Ralph H. Johnson VA Medical Center: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Vitamin D Deficiency; Fractures, Stress

Interventions

Cholecalciferol; RNA-Seq; Allostasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Gene Expression Profiling; Genetic Techniques; Investigative Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, RNA; Adaptation, Physiological; Adaptation, Biological; Biological Phenomena

Results Point of Contact

• Title: Stephen J. Savage, MD
• Organization: Medical University of South Carolina

savages@musc.edu

18437925787

Study Officials

• Chanita Hughes-Halbert, PhD

  MUSC Psychiatry and Behavioral Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single, open-label group

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 9, 2020
• Study Start: June 4, 2019
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)