Vitamin D in Treating Patients With Prostate Cancer
September 30, 2015 updated by: Roswell Park Cancer Institute
Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 120 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I
Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
|
Given orally
|
|
Experimental: Arm II
Patients receive 6,000 IU of vitamin D3 once daily.
|
Given orally
|
|
Experimental: Arm III
Patients receive 8,000 IU of vitamin D3 once daily.
|
Given orally
|
|
Experimental: Arm IV
Patients receive 10,000 IU of vitamin D3 once daily.
|
Given orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pattern of Response of Serum 25(OH) D3 Levels
Time Frame: Baseline, at 1, 3, 6 months
|
Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU.
Statistical analysis was done using one sample t-test.
|
Baseline, at 1, 3, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pattern of Response of Parathormone
Time Frame: Baseline, at 1, 3, 6 months
|
Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU.
Statistical analysis was done using one sample t-test.
|
Baseline, at 1, 3, 6 months
|
|
Toxicity
Time Frame: Baseline, at 1, 3 and 6 months
|
Number of treated patients that had serious adverse events.
|
Baseline, at 1, 3 and 6 months
|
|
Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls
Time Frame: Baseline, at 1, 3 ,6 months
|
Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls
|
Baseline, at 1, 3 ,6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
August 31, 2007
First Submitted That Met QC Criteria
August 31, 2007
First Posted (Estimate)
September 3, 2007
Study Record Updates
Last Update Posted (Estimate)
November 1, 2015
Last Update Submitted That Met QC Criteria
September 30, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000562742
- I 95406 (Other Identifier: Roswell Park Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.