Clinical trial · Interventional
Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.
Vitamin D and Prostate Cancer
NCT01045109CI-TRIAL-00033816D3/PCacompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- open-label vitamin D3
- description
- One arm: open-label receiving vitamin D3 4,000 IU daily
- interventionNames
- Dietary Supplement: cholecalciferol
Primary outcomes (1)
- measure
- Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.
- timeFrame
- 48 weeks
Secondary outcomes (1)
- measure
- Safety of subjects (determined by safety lab values every 8 weeks: serum Creatinine, Ca, Phosphorus, PTH, vit D3; CBC with differential; and urine Ca/Creat ratio) taking vitamin D3 supplementation (4,000 I.U.) daily.
- timeFrame
- 48 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * lowgrade prostate cancer * serum PSA less than/equal to 10 ng/ml * Gleason score less than/equal to 6 * referred from their treating physician with treatment plan of active surveillance for one year * serum creatinine less than/equal to 2.0 mg/dL * serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL * serum calcium greater than 8.5 and less than 10.5 mg/dL Exclusion Criteria: * concurrent malignancy, except non-melanoma skin cancer * history of sarcoidosis * history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation * history of hypercalcemia * treatment with lithium medication
References
Publications (1)
- DERIVEDGarrett-Mayer E, Wagner CL, Hollis BW, Kindy MS, Gattoni-Celli S. Vitamin D3 supplementation (4000 IU/d for 1 y) eliminates differences in circulating 25-hydroxyvitamin D between African American and white men. Am J Clin Nutr. 2012 Aug;96(2):332-6. doi: 10.3945/ajcn.112.034256. Epub 2012 Jul 3. PMID 22760568