Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00524680
Status:
COMPLETED
Last Update Posted:
2015-11-01
First Post:
2007-08-31
Brief Title:
Vitamin D in Treating Patients With Prostate Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Study of Serum 25OH D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 25OH 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 4000 IU of oral cholecalciferol vitamin D3 once daily
Arm II Patients receive 6000 IU of vitamin D3 once daily
Arm III Patients receive 8000 IU of vitamin D3 once daily
Arm IV Patients receive 10000 IU of vitamin D3 once daily Treatment in all arms continues for 6 months in the absence of disease progression or unacceptable toxicity
Primary
To examine the pattern of response of serum 25OH 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 4000 IU of oral cholecalciferol vitamin D3 once daily
Arm II Patients receive 6000 IU of vitamin D3 once daily
Arm III Patients receive 8000 IU of vitamin D3 once daily
Arm IV Patients receive 10000 IU of vitamin D3 once daily Treatment in all arms continues for 6 months in the absence of disease progression or unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I 95406 | OTHER | Roswell Park Cancer Institute | None |