Phase 2
Completed N=148
Vitamin D in Treating Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT00524680 ↗Enrolled (actual)
148
Serious AEs
5.4%
Results posted
Nov 2015
Primary outcomePrimary: Pattern of Response of Serum 25(OH) D3 Levels — 11.34; 24.84; 18.87; 26.91 ng/mL — p=<.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pattern of Response of Serum 25(OH) D3 Levels |
11.34; 24.84; 18.87; 26.91; 23.45; 38.31 | <.0001 sig |
| SECONDARY Pattern of Response of Parathormone |
-.73; -12.18; -1.28; -10.37; -11.3; .24 | 0.8244 |
| SECONDARY Toxicity |
2; 0; 1; 5 | — |
| SECONDARY Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls |
2; 0; 2; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00524680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.