Vitamin D Levels in Stage IV Colorectal Cancer Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-10-31

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.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vitamin D, vitamin D3

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.

Group Type EXPERIMENTAL

vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)

Intervention Type DRUG

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.

Interventions

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vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No