Completed

NCT Number: NCT00068276

Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

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.

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Key information

Conditions

Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Myeloid Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasms Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2006
First posted: Sep 11, 2003
Registry last updated: Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed