Clinical trial · Interventional
Vitamin D in Treating Patients With Prostate Cancer
Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
NCT00524680CI-TRIAL-00019669completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Vitamin D may be effective in treating patients with prostate cancer. PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.
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 (4)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
- interventionNames
- Dietary Supplement: cholecalciferol
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive 6,000 IU of vitamin D3 once daily.
- interventionNames
- Dietary Supplement: cholecalciferol
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Patients receive 8,000 IU of vitamin D3 once daily.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * 25(OH) D3 level \< 80 ng/mL PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-2 * Creatinine ≤ 2.0 mg/dL * Corrected serum calcium ≤ 10.5 mg/dL Exclusion criteria: * History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue) * Hypersensitivity to cholecalciferol or one of its components PRIOR CONCURRENT THERAPY: * No other concurrent vitamin D supplementation
References
Publications (0)
Data not yet available
No reference posted for this study.