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

Arm | Intervention/treatment |
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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.
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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. |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
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 |
Principal Investigator: | Kathleen Wesa, MD | Memorial Sloan Kettering Cancer Center |
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 |
Vitamin D Vitamin D3 colon cancer |
rectum cancer Cholecalciferol 09-143 |
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 |