Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
- To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol
(vitamin D3) supplementation at four different oral doses in patients with prostate
- To examine the pattern of response of parathormone (PTH) following vitamin D3
supplementation in these patients.
- To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.
- To track occurrence of infections, deep vein thrombosis, vascular events, and falls in
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
- Arm II: Patients receive 6,000 IU of vitamin D3 once daily.
- Arm III: Patients receive 8,000 IU of vitamin D3 once daily.
- Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms
continues for 6 months in the absence of disease progression or unacceptable toxicity.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pattern of response of serum 25(OH) D3 levels
Baseline, at 1, 3, 6 months
Donald L. Trump, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|