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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.
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.
Age
18 - 120 years
Sex
MALE
Healthy Volunteers
No
Roswell Park Cancer Institute
Buffalo, New York, United States
Start Date
June 1, 2007
Primary Completion Date
May 1, 2011
Completion Date
March 1, 2013
Last Updated
November 2, 2015
148
ACTUAL participants
cholecalciferol
DIETARY_SUPPLEMENT
Lead Sponsor
Roswell Park Cancer Institute
NCT06842498
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05691465