Cholecalciferol in Treating Patients With Myelodysplastic Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

September 10, 2003

Last Updated Date

February 6, 2009

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00068276 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

Official Title ^ICMJE

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 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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

Intervention ^ICMJE

Dietary Supplement: cholecalciferol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00068276

Responsible Party

Study ID Numbers ^ICMJE

CDR0000318802, CCCWFU-29203, CCCWFU-BG03-117

Study Sponsor ^ICMJE

Wake Forest University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:	Istvan Molnar, MD	Wake Forest University
Investigator:	Bayard L. Powell, MD	Wake Forest University

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP