RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-12-29
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05045066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * African American males, age \>= 18 years
  2. * Patients with a previous history of localized or metastatic or locally recurrent prostate cancer
  3. * Patients with Vitamin D levels below 30 ng/mL
  1. * Known hypersensitivity to vitamin D
  2. * End stage renal failure on dialysis
  3. * Liver cirrhosis
  4. * Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU/10mcg of vitamin D daily for the past month
  5. * Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature
  6. * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection
  7. * History of hypercalcemia

Contacts and Locations

Principal Investigator

Gerardo Colon-Otero, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-29
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2021-12-29
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Localized Prostate Carcinoma
  • Stage IV Prostate Cancer AJCC v8