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

RECRUITINGEarly 1Sponsored by Mayo Clinic
Actively Recruiting
PhaseEarly 1
SponsorMayo Clinic
Started2021-12-29
Est. completion2026-08-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* Pre-Registration:

  * 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
  * Legal inability or restricted legal ability, medical or psychological conditions not allowing proper study completion or informed consent signature
  * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection
  * History of hypercalcemia
* Registration:

  * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection

Conditions5

CancerLocalized Prostate CarcinomaLocally Recurrent Prostate CarcinomaMetastatic Prostate CarcinomaStage IV Prostate Cancer AJCC v8

Locations2 sites

Arizona

1 site
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office855-776-0015mayocliniccancerstudies@mayo.edu

Florida

1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office855-776-0015mayocliniccancerstudies@mayo.edu

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