Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Locally Recurrent Prostate Carcinoma | — | UNRESOLVED | — |
| Metastatic Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cholecalciferol)
- description
- 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.
- interventionNames
- Dietary Supplement: Cholecalciferol
- Other: Quality-of-Life Assessment
- Procedure: Biospecimen Collection
Primary outcomes (1)
- measure
- Change in circulating immunological cell function
- timeFrame
- Baseline; 8 weeks
- description
- Participants will have blood drawn to measure serum levels of 25-hydroxyvitamin D (25OHD) and to determine immune response. Laboratory endpoints for the levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared. A participant will be considered to have responded if they have developed a ≥3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity is undetectable, a positive response will be defined as ≥50 antigen-specific T cells/million PBMCs.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available