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

NCT ID: NCT05045066

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-29
• Study Completion Date: 2029-08-31

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.

Detailed Description

PRIMARY OBJECTIVE:

I. Determine the changes in circulating immunological cell function among patients with vitamin D insufficiency and the effects of vitamin D replacement on those changes.

SECONDARY OBJECTIVES:

I. Determine the prevalence of vitamin D insufficiency among black / African American (AA) prostate cancer patients.

II. Determine if there are differences in the peripheral blood immunological cell function in black/AA patients with metastatic or locally recurrent prostate cancer compared to those with localized prostate cancer.

III. Determine if vitamin D replacement is associated with improvement in prostate-specific antigen (PSA) progression free survival (PSA-PFS) of black/AA patients with prostate cancer with detectable changes in immune response compared to those with no detectable changes in immune response and compared to stage matched historical controls.

CORRELATIVE OBJECTIVE:

I. Determine if there are differences in the peripheral blood immunological cell function in Black/AA patients compared to West African/Black patients from Nigeria.

OUTLINE:

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

After completion of study treatment, patients are followed up at 56 days and then annually for 3 years.

Conditions

Localized Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Locally Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DIETARY_SUPPLEMENT

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Interventions

Cholecalciferol

Given PO

Intervention Type: DIETARY_SUPPLEMENT

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Biospecimen Collection

Undergo blood sample collection

Intervention Type: PROCEDURE

Other Intervention Names

9,10-Secocholesta-5,7,10(19)-trien-3-ol; Calciol; Delsterol; Vitamin D3; Quality of Life Assessment; Biological Sample Collection; Biospecimen Collected; Specimen Collection

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerardo Colon-Otero, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status: RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Cancer Center Clinical Trials

Role: CONTACT

866-273-4681 or 507-266-4000

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

HT94252411104

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PC230672P11

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCI-2021-08987

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-004555

Identifier Type: OTHER

Identifier Source: secondary_id

MC210501

Identifier Type: -

Identifier Source: org_study_id