Leukemia Clinical Trial
Official title:
Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial
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.
OBJECTIVES:
- Determine the efficacy of cholecalciferol, in terms of hematological improvement, in
patients with low- or intermediate-risk myelodysplastic syndromes.
- Determine the effect of this drug on disease symptoms, fatigue, and the overall
health-related quality of life of these patients.
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.
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