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NCT00068276 Clinical Trial

Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00068276
Other study ID # CCCWFU-29203
Secondary ID CDR0000318802CCC
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2003
Est. completion date September 2006

Study information
Verified date August 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 2006
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender All
Age group N/A to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• cholecalciferol

Locations
Country Name City State
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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