Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
Recruiting now · Early Phase 1
Conditions studied: Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05045066
- Run by
- Mayo Clinic
- People needed
- 220
- Starts
- 2021-12-29
- Expected to finish
- 2029-08-31
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (enrolling)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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