NCT00524680

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * 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 cancer. Secondary * 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. Tertiary * To track occurrence of infections, deep vein thrombosis, vascular events, and falls in these patients. 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferol	Given orally

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-05-01
• Completion: 2013-03-01
• First posted: 2007-09-03
• Last updated: 2015-11-02
• Results posted: 2015-11-02

Locations

1 site across 1 country: United States