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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

African American males, age >= 18 years

Patients with a previous history of localized or metastatic or locally recurrent prostate cancer

Patients with Vitamin D levels below 30 ng/ml

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cholecalciferol
  • Quality-of-Life Assessment
  • Biospecimen Collection

Treatment groups

220 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator