Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
About this 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.
- Condition
- Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma
- Tested
- Cholecalciferol, Quality-of-Life Assessment, Biospecimen Collection
- Sponsor
- Mayo Clinic
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma
- 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 9
- 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:
Where
2 sites, 2 recruiting
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Contact
-
Clinical Trials Referral Office
855-776-0015 mayocliniccancerstudies@mayo.edu
-
Cancer Center Clinical Trials
866-273-4681 or 507-266-4000
Potential match only. Final eligibility is determined by the study team.