Effects of vitamin D replacement on immune function in Black prostate cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early phase I trial investigates the prevalence of vitamin D insufficiency among Black/African American patients with localized or metastatic prostate cancer and its impact on immune function. The study aims to assess whether vitamin D replacement can normalize immune responses and improve health-related quality of life. Participants will receive daily cholecalciferol for eight weeks, with blood samples collected to evaluate changes in immunological cell function. The study also seeks to explore differences in immune responses between patients with localized and metastatic disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Gerardo Colon-Otero, M.D. — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.