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cholecalciferol · 1 trial · 3 indications
RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.
| Arm | Type | Description |
|---|---|---|
| Open label | OTHER | All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. |
| Name | Type | Description |
|---|---|---|
| cholecalciferol | DRUG | 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-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 |
| 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%). |
| 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 |
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 subj...
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Cholecalciferol, a form of vitamin D, is being studied for its effects on prostate cancer. In a Phase 2 clinical trial, it was evaluated in patients with prostate cancer and vitamin D deficiency. The study examined how vitamin D supplementation affects gene expression profiles in prostate tissue samples.
Cholecalciferol is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is investigating this small molecule as a potential treatment for prostate cancer.
Cholecalciferol is in Phase 2 clinical development for prostate cancer. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, with no active trials currently ongoing.
Cholecalciferol has been studied in one completed Phase 2 clinical trial, identified as NCT04621500. This trial, titled 'Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans,' enrolled 60 male participants aged 50 years and older in the United States.
Cholecalciferol is a form of vitamin D, specifically vitamin D3. It is a small molecule being investigated for its potential role in prostate cancer. The completed Phase 2 trial also included participants with vitamin D deficiency and stress reactions.