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

Inclusion Criteria5

  • 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 Criteria10

  • 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

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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