Vitamin D Levels in Stage IV Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074216
• Other study ID #: 09-143
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2010
• Last updated: January 4, 2016
• Start date: February 2010
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center