Vitamin D Levels in Stage IV Colorectal Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D, vitamin D3<br>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. | Drug: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)<br>* Patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Achieve Target Vitamin D Level | 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 | Within 6 weeks of beginning vitamin D | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Vitamin D3, colon cancer, rectum cancer, Cholecalciferol, 09-143