Clinical trial · Interventional
Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Vitamin D promotes the differentiation of prostate cancer cells and maintains the differentiated phenotype of prostate epithelial cells. The results of the investigators' clinical studies indicate that vitamin 1,25 dihydroxyvitamin D3 (VD3) supplementation results in a decrease of positive cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators hypothesize that Veterans who have early-stage prostate cancer and who take vitamin D3 at 4000 international units per day (intervention group) will show an improvement in the number of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of undergoing definitive treatment (prostatectomy or radiation therapy), compared to Veteran subjects taking placebo (control group).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- 4,000 IU of VD3 for one year
- interventionNames
- Drug: Vitamin D3
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- placebo for one year
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Pathology Status
- timeFrame
- one year
- description
- pathology status will be measured by the number of positive cores in prostate needle biopsy specimens between baseline and the repeat standard of care prostate biopsy at the end of the study.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Male 19 - 90 years old - Low-grade prostate cancer * Clinical Stage T1C or T2a * Serum PSA \< 10.0 ng/ml * Gleason Score \< or = to 6 (either architectural pattern \< or = to 3) * Decision to monitor prostate cancer in Active Surveillance * Serum creatinine \< 2.0 mg/dL * Serum phosphorus \> 2.3 and \< 4.8 mg/dL * Serum calcium \> 8.5 and \< 10.5 mg/dL * Must be capable of giving consent to participate in the study Exclusion Criteria: * Any concurrent malignancy, except non-melanoma skin cancer * History of sarcoidosis * History of Primary Hyperparathyroidism * History of hypercalcemia * Vitamin D supplementation \> 2,000 IU daily * Lithium medication
References
Publications (0)
Data not yet available