Clinical trial · Interventional
Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps
Vitamin D Intervention For Colon Cancer Prevention In African-Americans-A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI changed institutions and accrual was not completed.
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps. PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it works compared with a placebo in preventing colorectal cancer in African Americans with colon polyps.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Dietary Supplement: cholecalciferol
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: placebo
Primary outcomes (2)
- measure
- Rate of compliance as assessed at 6 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenomatous polyp * At least 1 adenoma * Self-identified as an African American AND undergoing screening or diagnostic colonoscopy at the University of Chicago * No history of colon or rectal cancer or hereditary or familial colon cancer (e.g., hereditary non-polyposis colon cancer or familial adenomatous polyposis) PATIENT CHARACTERISTICS: * Total bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine normal * Albumin ≥ 3.0 mg/dL * Baseline serum calcium level normal * Not pregnant * No history of thyroid disease * No history of renal stones PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No other concurrent vitamin D intake
References
Publications (0)
Data not yet available