Effects of vitamin D replacement on immune function in Black 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
EARLY_PHASE1 · Mayo Clinic · NCT05045066
This study is testing if giving vitamin D to Black men with prostate cancer can help their immune system work better and improve their overall health.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Trial ID | NCT05045066 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are African American males aged 18 and older with a history of localized or metastatic prostate cancer and low vitamin D levels.
Not a fit: Patients with known hypersensitivity to vitamin D, end-stage renal failure, or those currently taking high doses of vitamin D supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved immune function and potentially better outcomes for Black prostate cancer patients through vitamin D supplementation.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated a potential link between vitamin D levels and prostate cancer outcomes, suggesting a promising area of investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma