Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
Recruiting · NCT05045066 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 2 US states.
- Mayo Clinic in Arizona - Scottsdale, Arizona, United States
- Mayo Clinic in Florida - Jacksonville, Florida, United States