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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05045066
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cholecalciferol — DIETARY_SUPPLEMENT
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

Start date
Dec 29, 2021
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2029

Study Design

Enrollment
220 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cholecalciferol)
    Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.

Primary Outcome Measure

Change in circulating immunological cell function [ Time Frame: Baseline; 8 weeks ]

Central Contacts

  • Clinical Trials Referral Office
    855-776-0015
    [email protected]
  • Cancer Center Clinical Trials
    866-273-4681 or 507-266-4000

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Cassandra N. Moore, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Gerardo Colon-Otero, M.D. (PRINCIPAL_INVESTIGATOR)

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