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Vitamin D Levels in Stage IV Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT01074216
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study
Study Start Date : February 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074216


Locations
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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
Investigators
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Principal Investigator: Kathleen Wesa, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01074216    
Other Study ID Numbers: 09-143
First Posted: February 24, 2010    Key Record Dates
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016
Last Verified: January 2016
Keywords provided by Memorial Sloan Kettering Cancer Center:
Vitamin D
Vitamin D3
colon cancer
 rectum cancer
Cholecalciferol
09-143
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Vitamin D
Vitamins
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents