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

Launched by MAYO CLINIC · Sep 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how common low levels of vitamin D are among African American men who have had prostate cancer, whether it was localized (not spread) or metastatic (spread to other parts of the body). The researchers want to understand how low vitamin D levels affect the immune system and whether giving vitamin D supplements can help improve immune function. This is important because low vitamin D levels have been linked to more aggressive forms of prostate cancer, and identifying this issue may help patients receive better care.

To be eligible for the study, participants must be African American males aged 18 and older who have a history of localized or metastatic prostate cancer and have low vitamin D levels (below 30 ng/mL). Those who have serious health issues, such as severe kidney problems, liver disease, or who are currently taking high doses of vitamin D, may not be able to participate. If selected, participants will receive vitamin D supplements and will be monitored to see how their immune system responds. This trial is currently recruiting participants, and those who join could help improve our understanding of how vitamin D affects prostate cancer treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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