Clinical trial · Interventional
High Dose Vitamin D Study
Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients
- 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 investigate the therapeutic effect and the safety of high-dose vitamin D supplementation in metastatic colorectal cancer patients. We propose to supplement metastatic (stage 4) colorectal cancer patients with oral doses of vitamin D to raise serum 25-hydroxy-vitamin D \[25(OH)D\] levels to the high normal range of 200-250 nmol/L. The primary objective of this study is to evaluate the metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. The secondary objective is to evaluate patient survival with regards to high-dose vitamin D supplementation. Hypothesis: Whereas low doses of vitamin D reportedly play a significant role in prevention of colorectal cancers, do much larger (pharmacological) doses of vitamin D have a significant therapeutic effect against the same kind of cancer?
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 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Dietary Supplement (e.g., vitamins, minerals)
- description
- Experimental arm is supplemented with high-dose of vitamin D.
- interventionNames
- Drug: Vitamin D
- type
- NO_INTERVENTION
- label
- No Intervention
Primary outcomes (2)
- measure
- The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
- timeFrame
- After 16 months of intervention
- measure
- The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (We will recruit stage 4 (metastatic) colorectal cancer patients who are clients at InspireHealth): * Age \> 18 * Histologically confirmed colon or rectal cancer * Known metastatic disease (stage-4) confirmed histologically or radiologically * Life expectancy of \>8 months * May receive anti-neoplastic therapy at the discretion of their physician * Stable metastatic disease defined as no change in systemic for the month before and the month after commencing study * Signed informed consent Exclusion Criteria(Stage 4 colorectal cancer patients): * Pregnant / lactating women * Known hypersensitivity to vitamin D * Pre-existing renal stone disease based on history * Pre-existing hypercalcemia * Severe renal or hepatic dysfunction (≥ 2x of the upper normal range) * granulomatous disease (TB and sarcoid) * unable to give informed consent in English (translations of study documents in languages other than English will not be provided)
References
Publications (0)
Data not yet available