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Recruiting
NCT05045066
Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
Conditions: Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 220
Sponsor: Mayo Clinic
Location: Mayo Clinic in Arizona Scottsdale Arizona
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.
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
Source: ClinicalTrials.gov (NCT05045066). StuddyBuddy aggregates publicly available trial information.