Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00068276

Enrollment

Unknown

Registered

2003-09-11

Start date

2003-07-31

Completion date

2006-09-30

Last updated

2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myelodysplastic/Myeloproliferative Neoplasms, Myelodysplastic Syndromes

Keywords

previously treated myelodysplastic syndromes, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, childhood myelodysplastic syndromes

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 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.

Interventions

DIETARY_SUPPLEMENTcholecalciferol

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed myelodysplastic syndromes (MDS) * Must have undergone bone marrow aspirate and biopsy with karyotype within the past 3 months * International Prognostic Scoring System score of 0 or 1 PATIENT CHARACTERISTICS: Age * Any age Performance status * Any Life expectancy * More than 1 year Hematopoietic * Not specified Hepatic * Not specified Renal * No history of hypercalcemia PRIOR CONCURRENT THERAPY: Biologic therapy * Prior stem cell transplantation allowed * No concurrent hematopoietic growth factors Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 6 weeks since prior cholecalciferol supplements or analogs * More than 4 weeks since any prior therapy for MDS (except supportive care) * No other concurrent therapy for MDS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026