Recruiting
Early Phase 1

Vitamin D Replacement

Sponsor:

Mayo Clinic

Code:

NCT05045066

Conditions

Localized Prostate Carcinoma

Stage IV Prostate Cancer AJCC v8

Locally Recurrent Prostate Carcinoma

Metastatic Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cholecalciferol

Quality-of-Life Assessment

Biospecimen Collection

Study Details

Brief summary:

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.

Conditions

Localized Prostate Carcinoma

Stage IV Prostate Cancer AJCC v8

Locally Recurrent Prostate Carcinoma

Metastatic Prostate Carcinoma

Study ID

NCT05045066

Start date

Dec 29, 2021

Status verified date

Jun, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (cholecalciferol)

Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.

Interventions

Cholecalciferol

Given PO

Quality-of-Life Assessment

Ancillary studies

Biospecimen Collection

Undergo blood sample collection

Primary outcome measure

  • Change in circulating immunological cell function [ Time Frame: Baseline; 8 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

866-273-4681 or 507-266-4000

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Cassandra N. Moore, M.D.

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Gerardo Colon-Otero, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-08.