NCT00068276

Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 120 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferol

Timeline

• Start date: 2003-07-01
• Primary completion: 2005-06-01
• Completion: 2006-09-01
• First posted: 2003-09-11
• Last updated: 2018-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study