Clinical trial · Interventional
Vitamin D Levels in Stage IV Colorectal Cancer Patients
Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study
- 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 find out what effects, good and/or bad, vitamin D blood levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to increase low vitamin D levels into normal range using vitamin D supplements taken by mouth. Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given would be considered standard of care.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vitamin D, vitamin D3
- description
- This is a Phase II study involving Stage IV colorectal cancer patients with serum vitamin D deficiency, to determine the ability to correct vitamin D deficiency and to maintain serum vitamin D levels (25-hydroxy vitamin D) once achieved.
- interventionNames
- Drug: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
Primary outcomes (1)
- measure
- To Achieve Target Vitamin D Level
- timeFrame
- Within 6 weeks of beginning vitamin D
- description
- To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with Stage IV (metastatic) colorectal cancer * Baseline 25-hydroxy vitamin D level \< 30 ng/ml * Age ≥18 years of age Exclusion Criteria: * Current or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \> 3 years * Albumin \< 3.2 * Patients on concurrent chronic steroids, other than those allowed for routine antiemetics, or inhaled steroids * Patients receiving phenobarbital, phenytoin, orlistat and cholestyramine * Hypercalcemia (Calcium \>10.5 mg/dl) * Calcium x Phosphorus \> 70 mg2/dL2
References
Publications (0)
Data not yet available