MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black/ African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease
Mayo Clinic
Summary
This early phase I is to find out how common vitamin D insufficiency is among African American patients with a history of prostate cancer that has not spread to other parts of the body (localized) or has spread to other places in the body (metastatic) and how vitamin D insufficiency affects the immune system. This study also aims to find out if replacing vitamin D results in normalization of the immune function. Information from this study may benefit prostate cancer patients by identifying vitamin D insufficiency which in several studies had been found to contribute to more aggressive prostate cancers.
Description
PRIMARY OBJECTIVE: I. Determine the changes in circulating immunological cell function among patients with vitamin D insufficiency and the effects of vitamin D replacement on those changes. SECONDARY OBJECTIVES: I. Determine the prevalence of vitamin D insufficiency among black / African American (AA) prostate cancer patients. II. Determine if there are differences in the peripheral blood immunological cell function in black/AA patients with metastatic or locally recurrent prostate cancer compared to those with localized prostate cancer. III. Determine if vitamin D replacement is associat…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Pre-Registration: * African American males, age \>= 18 years * Patients with a previous history of localized or metastatic or locally recurrent prostate cancer * Registration: * Patients with Vitamin D levels below 30 ng/ml Exclusion Criteria: * Pre-Registration: * Known hypersensitivity to vitamin D * End stage renal failure on dialysis * Liver cirrhosis * Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU/10mcg of vitamin D daily for the past month * Legal inability or restricted legal ability, medical or psychologic…
Interventions
- Dietary SupplementCholecalciferol
Given PO
- OtherQuality-of-Life Assessment
Ancillary studies
- ProcedureBiospecimen Collection
Undergo blood sample collection
Locations (2)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in FloridaJacksonville, Florida