NCT05045066RecruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 25 Aug 2021
- Start date
- 29 Dec 2021
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Mayo Clinic
- Diseases
- Prostate cancer
- NCT number
- NCT05045066
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 220
- From 29 Dec 2021 to the primary completion date, 31 Aug 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.