Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
148 participants
INTERVENTIONAL
2007-06-30
2013-03-31
Brief Summary
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PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
cholecalciferol
Given orally
Arm II
Patients receive 6,000 IU of vitamin D3 once daily.
cholecalciferol
Given orally
Arm III
Patients receive 8,000 IU of vitamin D3 once daily.
cholecalciferol
Given orally
Arm IV
Patients receive 10,000 IU of vitamin D3 once daily.
cholecalciferol
Given orally
Interventions
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cholecalciferol
Given orally
Eligibility Criteria
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Inclusion Criteria
* Creatinine ≤ 2.0 mg/dL
* Corrected serum calcium ≤ 10.5 mg/dL
Exclusion Criteria
* Hypersensitivity to cholecalciferol or one of its components
PRIOR CONCURRENT THERAPY:
* No other concurrent vitamin D supplementation
18 Years
120 Years
MALE
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Donald L. Trump, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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I 95406
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000562742
Identifier Type: -
Identifier Source: org_study_id
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