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Vitamin D Replacement for Black/African American Prostate Cancer Patients

This study is looking at how common low vitamin D levels are in Black/African American men with prostate cancer, whether it's localized (hasn't spread) or metastatic (has spread). Researchers want to see if low vitamin D affects the immune system and if taking cholecalciferol (a form of vitamin D) can improve immune function. The goal is to understand if vitamin D replacement can help prostate cancer patients, especially since low vitamin D has been linked to more aggressive prostate cancers. You may be able to join if you are an African American male, 18 or older, with a history of prostate cancer and vitamin D levels below 30 ng/ml. The main goal is to measure changes in immune cell function after 8 weeks of treatment. This study is currently recruiting 220 participants.

Study design
This is an interventional study, meaning participants will receive a treatment. It is a single-arm study, with 220 planned participants.
What's involved
If you join, you will take cholecalciferol by mouth daily for 8 weeks. You will also have blood samples collected throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After completing the 8 weeks of treatment, you will be followed up at 56 days and then annually for 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05045066

Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~220 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:CholecalciferolQuality-of-Life AssessmentBiospecimen Collection

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in circulating immunological cell function
Measured over Baseline; 8 weeks

Conditions

Localized Prostate Carcinoma
Stage IV Prostate Cancer AJCC v8
Locally Recurrent Prostate Carcinoma
Metastatic Prostate Carcinoma

Explore related trials

Prostate CarcinomaErgocalciferol

Where it's being run

2 sites across 2 states
Arizona1
Florida1

Study leadership

  • Gerardo Colon-Otero, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in circulating immunological cell functionBaseline; 8 weeks

    Participants will have blood drawn to measure serum levels of 25-hydroxyvitamin D (25OHD) and to determine immune response. Laboratory endpoints for the levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared. A participant will be considered to have responded if they have developed a ≥3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity is undetectable, a positive response will be defined as ≥50 antigen-specific T cells/million PBMCs.