Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00068276|
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : January 19, 2017
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 or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Dietary Supplement: cholecalciferol||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||September 2006|
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): NCT00068276
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|Study Chair:||Istvan Molnar, MD||Wake Forest University Health Sciences|
|OverallOfficial:||Bayard L. Powell, MD||Wake Forest University Health Sciences|