Clinical trial · Interventional
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer
NCT03290417CI-TRIAL-00043488completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to see if eating vitamin D, omega 3 and turmeric (curcumin) slows the growth of prostate cancer in men on active surveillance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omega-3 | Dietary Supplement | — | UNRESOLVED |
| Turmeric | Dietary Supplement | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Unmodified Diet
- description
- Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer
- type
- EXPERIMENTAL
- label
- Diet modification
- description
- Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements
- interventionNames
- Dietary Supplement: Vitamin D
- Dietary Supplement: Omega-3
- Dietary Supplement: Turmeric
Primary outcomes (2)
- measure
- gene expression of very low and low risk prostate cancer patients on Active Surveillance
- timeFrame
- Up to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Subjects must have the diagnosis of prostate cancer and be on active surveillance. For the purpose of this study, Active surveillance implies prostate-specific antigen (PSA)\<10 ng/mL, biopsy Gleason sum \</=6 with no pattern 4 or 5, cancer involvement of \<33% of biopsy cores, and clinical stage T1/T2a tumor. * Subjects must be followed at the Cleveland Clinic for active surveillance. * Subjects must be willing to adhere to the dietary modification outlined in the protocol. * Subjects must be willing to have prostate biopsies at the baseline, and six months after enrollment into the protocol * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Subjects receiving any treatment other than AS for prostate cancer. * Subjects not followed by the Cleveland Clinic. * Subjects unable to adhere to the dietary modification outlined in the protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.