Phase 2
Completed N=54
Vitamin D Levels in Stage IV Colorectal Cancer Patients
Source: ClinicalTrials.gov NCT01074216 ↗Enrolled (actual)
54
Serious AEs
24.1%
Results posted
Feb 2016
Primary outcomePrimary: To Achieve Target Vitamin D Level — 41 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Achieve Target Vitamin D Level |
41 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with Stage IV (metastatic) colorectal cancer
- Baseline 25-hydroxy vitamin D level 3 years
- Albumin 10.5 mg/dl)
- Calcium x Phosphorus > 70 mg2/dL2
Data sourced from ClinicalTrials.gov (NCT01074216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.