Clinical Trial: Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Wake Forest University Health Sciences
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Wake Forest University Health Sciences
Dates:
Date Received: September 10, 2003
Date Started: July 2003
Date Completion:
Last Updated: January 17, 2017
Last Verified: June 2013
