Clinical trial · Interventional
DNA Changes That Affect Vitamin D Metabolism in Patients With Colorectal Cancer Receiving Vitamin D Supplements
Identification of 24-Hydroxylase Polymorphisms and Splicing Variants That Modulate Vitamin D Oxidative Metabolism and Serum Pharmacokinetics in Patients With Colorectal Cancer on Cholecalciferol Therapy
- 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)
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is studying changes in DNA that affect vitamin D metabolism in patients with colorectal cancer receiving vitamin D supplements.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| immunoscintigraphy | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Cholecalciferol
- description
- Patients receive oral cholecalciferol 2000 IU once daily for 1 year
- interventionNames
- Dietary Supplement: cholecalciferol
- Genetic: polymerase chain reaction
- Genetic: polymorphism analysis
- Genetic: protein expression analysis
- Genetic: reverse transcriptase-polymerase chain reaction
- Genetic: western blotting
- Other: high performance liquid chromatography
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Procedure: adjuvant therapy
- Procedure: immunoscintigraphy
Primary outcomes (5)
- measure
- Identification of CYP24 single nucleotide polymorphisms (SNPs)
- timeFrame
- Baseline, days 14, 30, 60, 90, 180, 270, 360
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Prior or current documented diagnosis of colorectal cancer * All stages * 25OH-D3 level \< 50 ng/mL PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 6 months * Serum creatinine \< 2.0 mg/dL * Serum bilirubin \< 2.0 mg/dL * No prior or current hypercalcemia (defined as albumin corrected serum calcium \< 10.2 mg/dL) * No known contraindication for vitamin D supplementation * No genitourinary stones within the past 5 years * No severe comorbid conditions such as uncompensated heart failure or active infection PRIOR CONCURRENT THERAPY: * No supplemental vitamin D beyond what is provided through the study * At least 2 months since prior vitamin D supplementation exceeding 800 International Units (IU) * Nondietary vitamin D supplements should not have exceeded 800 IU/day within the past 2 months
References
Publications (0)
Data not yet available