Vitamin D Levels in Stage IV Colorectal Cancer Patients

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT01074216

Run by

Memorial Sloan Kettering Cancer Center

People needed

45

Starts

2010-02-01

Expected to finish

2014-10-01

Last updated by the study team

2016-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Stage IV (metastatic) colorectal cancer
• Baseline 25-hydroxy vitamin D level < 30 ng/ml
• Age ≥18 years of age

You may not qualify if…

• 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

Where it is running

• Memoral Sloan Kettering Cancer Center — Basking Ridge, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center @ Suffolk — Commack, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan-Kettering at Mercy Medical Center — Rockville Centre, New York, United States
• Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital — Sleepy Hollow, New York, United States

Full record on ClinicalTrials.gov

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