- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04621500
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans (VitD/RNA-seq)
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans
Study Overview
Status
Conditions
Intervention / Treatment
- 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 Measurements at baseline and after one year vitamin D3 supplementation
Detailed Description
This is an open-label pilot study. The goal is to investigate the transcription and biological pathways in prostate cancer that are especially relevant to prostate cancer disparities between African American and Caucasian men. Also, to determine any significant differences in the molecular signature that exist in African American and Caucasian men in relation to their Vitamin D levels.
Recruitment will be at the Urology Clinic at the Ralph H. Johnson VA Medical Center in Charleston, SC. Men who are scheduled for a Standard of Care prostate biopsy will be consented for their permission to collect an extra prostate tissue core for RNA-sequencing.
After the pathology report is discussed by their Urologist, and the treatment decision is Active Surveillance, the participant is enrolled into the Intervention Phase. At that time, baseline allostatic load measurements (Blood pressure, pulse, waist/hip ratio, height, and weight for BMI) and bloodwork: (lipid panel, HgbA1c, albumin and creatinine, IL-6, CRP, and DHEA-s (inflammatory markers) plus a Vitamin D level, will be collected. Vitamin D3 soft gels (4,000 IU) daily (six months' supply) will be dispensed. A Social Determinants survey will also be dispensed for subject completion.
At the Urology Standard of Care six-month follow-up appointment, the vitamin D serum level will be collected and the next six months' supply of vitamin D3 will be dispensed.
At the Urology Standard of Care follow-up (repeat at 1 year) surveillance prostate biopsy, an extra prostate tissue core will be collected for RNA-sequencing. The allostatic load measurements and bloodwork will also be obtained.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29401
- Ralph H. Johnson VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- current vitamin D3 supplementation > 2,000 IU daily
- inability or unwillingness to continue to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Open label
All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
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Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year
Other Names:
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
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 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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in transcriptional profiles after vitamin D supplementation.
Time Frame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
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RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.
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Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histopathology changes in the Gleason Score on repeat biopsy findings after vitamin D supplementation
Time Frame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
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The first reported finding in the pathology report is the Gleason Score. When the prostate sample is examined under the microscope, the Pathologist determines which type of cell is the most common and which type is the second most common. Each of these cell types is given a score from 1 to 5. Higher numbers mean more abnormal, aggressive cancer cells. Because the two most common types of cancer cells are identified, the Gleason Score is a combination of these two cell types. For example, the first most common cell type is a 3 and the second is reported as a 4, then the Gleason Score is 3+4, or 7. Changes to the baseline and repeat prostate biopsy Gleason Score will be analyzed. |
Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
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Histopathology changes in the number of positive cores on repeat biopsy findings after vitamin D supplementation.
Time Frame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
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During a routine prostate biopsy, 12 core samples are collected: 2 samples from the top right, front and back, 2 from the top left, front and back; 2 from the middle right and 2 from the middle left; 2 from the bottom right and 2 from the bottom left. When the 12 cores are examined under the microscope, the Pathologist identifies which cores contain cancer cells (or are positive for cancer). Therefore, the pathology report will identify the number of positive cores between 0 to 12. Changes to the baseline and repeat prostate biopsy positive core will be analyzed. |
Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
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Histopathology changes in the highest percentage of core involvement on repeat biopsy findings after vitamin D supplementation.
Time Frame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
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When the Pathologist examines the 12 core samples from the prostate biopsy, the percentage of cancer cells that are in each core is also identified. This can be from 0 to 100 percent involvement. To facilitate the evaluation of the 12 percentages reported for the 12 cores in the pathology report, the Urology standard is to prioritize and assess the highest percentage of core involvement. Changes to the baseline and repeat biopsy highest percentage core involvement will be analyzed. |
Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
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Identify changes in molecular signature that exist in AA and Caucasian men in relation to vitamin D levels
Time Frame: Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits
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RNA-seq analyses of prostate tissue plus allostatic load measurements to determine stress response
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Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Chanita Hughes-Halbert, PhD, MUSC Psychiatry and Behavioral Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Fractures, Bone
- Wounds and Injuries
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Vitamin D Deficiency
- Fractures, Stress
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- 00085140
- 5U54MD010706-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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