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| Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068276 |
Purpose
RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome.
PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients with myelodysplastic syndrome.
| Condition | Intervention | Phase |
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cholecalciferol |
Phase II |
| MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| Drug Information available for: | Vitamin D Ergocalciferol Cholecalciferol |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial |
| Study Start Date: | July 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, pilot study.
Patients receive oral cholecalciferol once daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed myelodysplastic syndromes (MDS)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, North Carolina | |||||
| Comprehensive Cancer Center at Wake Forest University | |||||
| Winston-Salem, North Carolina, United States, 27157-1082 | |||||
| Wake Forest University |
| National Cancer Institute (NCI) |
| Study Chair: | Istvan Molnar, MD | Wake Forest University |
| Investigator: | Bayard L. Powell, MD | Wake Forest University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000318802, CCCWFU-29203, CCCWFU-BG03-117 |
| First Received: | September 10, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068276 |
| Health Authority: | United States: Federal Government |
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