Clinical trial · Interventional
Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer
- 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, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical prostate cancer to clinical disease. The investigators propose to conduct a clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease monitored through active surveillance. The successful completion of this proposed clinical study will allow us to determine whether correcting vitamin D deficiency in Veterans diagnosed with early-stage prostate cancer will prevent progression of their disease and improve their prognosis.
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 daily for one year | Drug | — | UNRESOLVED |
| vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D3
- description
- 4,000 IU vitamin D3 daily for one year
- interventionNames
- Drug: vitamin D3
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo daily for one year
- interventionNames
- Drug: Placebo daily for one year
Primary outcomes (1)
- measure
- PSA Slope (Trajectory) or the Change in PSA Level Over Time
- timeFrame
- 1 year (visits # 1-8)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Male Veterans (\> 18 years of age) recently diagnosed with low-risk PCa (histologically documented adenocarcinoma of the prostate) * A serum PSA value of up to 10.0 ng/ml, and a Gleason score of six or less (three or less in either architectural pattern) * For the purpose of eligibility, these additional criteria will be verified: \*serum creatinine 2.0 mg/dL * serum phosphate (measured as phosphorus) \> 2.3 and \< 4.8 mg/dL * serum calcium \> 8.5 and \< 10.5 mg/dL Exclusion Criteria: * Subjects with any concurrent malignancy, except non-melanoma skin cancer * Subjects with a history of sarcoidosis * Subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation * Subjects with a history of hypercalcemia * Subjects who use lithium as a medication
References
Publications (0)
Data not yet available