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Vitamin D Levels in Stage IV Colorectal Cancer Patients

This study has been completed.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center Identifier:
First received: February 22, 2010
Last updated: January 4, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Colorectal Cancer
Drug: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • To Achieve Target Vitamin D Level [ Time Frame: Within 6 weeks of beginning vitamin D ]
    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

Enrollment: 45
Study Start Date: February 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01074216

United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
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
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Principal Investigator: Kathleen Wesa, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT01074216     History of Changes
Other Study ID Numbers: 09-143
Study First Received: February 22, 2010
Results First Received: January 4, 2016
Last Updated: January 4, 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
Vitamin D
Vitamin D3
colon cancer
rectum cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017