RecruitingEarly Phase 1NCT05045066

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


Sponsor

Mayo Clinic

Enrollment

220 participants

Start Date

Dec 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether vitamin D supplementation can improve immune function in Black and African American men with prostate cancer who have low vitamin D levels — a common finding in this population that may be linked to worse health outcomes. **You may be eligible if...** - You are an African American male, 18 or older - You have a history of localized, locally recurrent, or metastatic prostate cancer - Your vitamin D level is below 30 ng/mL **You may NOT be eligible if...** - You have a known allergy to vitamin D - You have end-stage kidney failure on dialysis - You have liver cirrhosis - You are already taking more than 400 IU/day of vitamin D - You have a history of high calcium levels (hypercalcemia) - You have had chemotherapy, surgery, or radiation within the past 3 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTCholecalciferol

Given PO

OTHERQuality-of-Life Assessment

Ancillary studies

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT05045066


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