Actively Recruiting

Early Phase 1
Age: 18Years +
MALE
NCT05045066

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

Led by Mayo Clinic · Updated on 2026-03-02

220

Participants Needed

2

Research Sites

400 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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 containing more than 400 IU daily in the past month
  • Medical or psychological conditions preventing study completion or informed consent
  • Chemotherapy, surgery, or radiation within the last 3 weeks prior to blood collection
  • History of high blood calcium levels

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

C

Clinical Trials Referral Office

CONTACT

C

Cancer Center Clinical Trials

CONTACT

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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