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MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black/ African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Cholecalciferol+Quality-of-Life Assessment
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Dietary supplement, Procedure
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Backup
Cancer Center Clinical Trials
866-273-4681 or 507-266-4000
Time Frame
Start Date: 2021-12-29
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 220
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: Congressionally Directed Medical Research Programs

This content was sourced from clinicaltrials.gov