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Vitamin D Levels in Stage IV Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 22, 2010
First Posted Date  ICMJE February 24, 2010
Results First Submitted Date  ICMJE January 4, 2016
Results First Posted Date  ICMJE February 3, 2016
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE February 2010
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2010)
Vitamin D level [ Time Frame: w/i 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 newly diagnosed metastatic colon cancer.
Change History Complete list of historical versions of study NCT01074216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2010)
  • length of time required to achieve serum vitamin D levels [ Time Frame: 2 years ]
    To determine the length of time required to achieve serum vitamin D levels ≥40 ng/ml through vitamin D supplementation in patients with newly diagnosed metastatic colon cancer.
  • ability to maintain serum vitamin D levels ≥40 ng/ml [ Time Frame: 2 years ]
    The ability to maintain serum vitamin D levels ≥40 ng/ml with daily vitamin D maintenance.
  • describe serial PTH levels and explore the correlation between normalization of vitamin D levels and normalization of PTH levels [ Time Frame: 2 years ]
    To describe serial PTH levels and explore the correlation between normalization of vitamin D levels and normalization of PTH levels in metastatic colon cancer patients.
  • To explore interactions between other medications and vitamin D repletion. [ Time Frame: 2 years ]
  • To evaluate the safety of vitamin D supplementation. [ Time Frame: 2 years ]
  • To estimate overall survival. [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Levels in Stage IV Colorectal Cancer Patients
Official Title  ICMJE Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2014)
45
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2010)
49
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01074216
Other Study ID Numbers  ICMJE 09-143
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathleen Wesa, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP