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

NCT05045066 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Mayo Clinic

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-29
Primary Completion
2026-08-31
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05045066 on ClinicalTrials.gov