No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for African American men aged 18 or older who have a history of prostate cancer. Participants will be tested for vitamin D levels, and if low, will receive vitamin D replacement to see how it affects their immune system.
Are You a Good Fit for This Trial?
You may be able to join if
I am an African American male
I am at least 18 years old
I have a history of localized prostate cancer
I have a history of metastatic prostate cancer
I have a history of locally recurrent prostate cancer
My vitamin D levels are below 30 ng/ml
You may not be able to join if
I am allergic to vitamin D
I am on dialysis for kidney failure
I have liver cirrhosis
I have taken vitamin D or multivitamin supplements with more than 400 IU for the past month
I cannot legally consent or complete the study due to medical or psychological issues
I have had chemotherapy, surgery, or radiation in the last 3 weeks
I have a history of high calcium levels
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 i…
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.
Trial Locations
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Status
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:
…
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
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