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Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black/ African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease
Who can join
Ages 18 and older · Men
Full eligibility criteria
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 psychological conditions not allowing proper study completion or informed consent signature * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection * History of hypercalcemia * Registration: * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection
About the study
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.
What is being tested
- Cholecalciferol (dietary supplement)
- Quality-of-Life Assessment (other)
- Biospecimen Collection (procedure)
Sponsor: Mayo Clinic · Participants: 220 · Started: Dec 29, 2021
Contact the study team
- Clinical Trials Referral Office · Phone: 855-776-0015
- Cancer Center Clinical Trials · Phone: 866-273-4681 or 507-266-4000
Official record on ClinicalTrials.gov — NCT05045066
Locations in the U.S.
| Arizona | Mayo Clinic in Arizona, Scottsdale |
| Florida | Mayo Clinic in Florida, Jacksonville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.