Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black/ African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease
About This Trial
- This study is testing whether taking vitamin D supplements can help strengthen the immune system in Black or African American men who have had prostate cancer.
- To join, you must be at least 18 years old and have low levels of vitamin D, whether your cancer was caught early or has spread.
- Researchers want to see if bringing vitamin D back to normal levels helps the body's natural defenses fight cancer more effectively.
- Before considering this trial, you should know that you cannot participate if you already take daily vitamin D supplements, have severe kidney or liver disease, or have received surgery, radiation, or chemotherapy in the past three weeks.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing whether taking vitamin D supplements can help strengthen the immune system in Black or African American men who have had prostate cancer.
Study Details
- Start Date: December 29, 2021
- Lead Sponsor: Mayo Clinic
Full Eligibility Criteria
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
Treatments
- Dietary Supplement: Cholecalciferol
- Other: Quality-of-Life Assessment
- Procedure: Biospecimen Collection