Actively Recruiting
Differences in Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients With Localized Versus Metastatic Disease
Led by Mayo Clinic · Updated on 2026-06-08
220
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying vitamin D insufficiency in African American men who have had prostate cancer, whether it is localized, locally recurrent, or metastatic. The study aims to understand how low vitamin D levels affect the immune system and whether replacing vitamin D can normalize immune function. This early phase I trial also explores differences in immune cell function between patients at different stages of prostate cancer and compares immune responses with those of West African patients from Nigeria. Participants with low vitamin D levels will take cholecalciferol (a form of vitamin D) by mouth daily for 8 weeks, as long as no unacceptable side effects occur. Blood samples will be collected throughout the treatment period to monitor immune cell function. After treatment, patients will be followed up at 56 days and then annually for up to 3 years to observe longer-term effects, including prostate-specific antigen progression free survival. During the study, participants will undergo blood tests and quality-of-life assessments. Researchers will measure changes in immune cell function from the start of the study to 8 weeks after treatment begins. They will also track vitamin D insufficiency prevalence and the possible link between vitamin D replacement and prostate cancer progression over several years. The study will monitor safety and immune response changes throughout the follow-up period.
CONDITIONS
Brief Title
Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- African American males aged 18 years or older
- History of localized, metastatic, or locally recurrent prostate cancer
- Vitamin D levels below 30 ng/ml
You will not qualify if you...
- Known allergy to vitamin D
- End stage renal failure requiring dialysis
- Liver cirrhosis
- Taking vitamin D or multivitamin supplements with more than 400 IU of vitamin D daily in the past month
- Medical or psychological conditions preventing study completion or informed consent
- Chemotherapy, surgery, or radiation treatment within 3 weeks before blood collection
- History of high blood calcium levels (hypercalcemia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants with low vitamin D3 levels receive cholecalciferol orally daily for 8 weeks in the absence of unacceptable toxicity. Blood samples are collected throughout this period to monitor immunological cell function and vitamin D levels.
Multiple visits for blood sample collection during treatment
Duration - Up to 3 years
After completing vitamin D treatment, participants are followed up at 56 days and then annually for 3 years to monitor PSA progression free survival and immune response.
1 visit at 56 days post-treatment and annual visits for 3 years
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
C
Cancer Center Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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