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Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences Identifier:
First received: September 10, 2003
Last updated: January 17, 2017
Last verified: June 2013

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.

Condition Intervention Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Dietary Supplement: cholecalciferol Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial

Resource links provided by NLM:

Further study details as provided by Wake Forest University Health Sciences:

Study Start Date: July 2003
Study Completion Date: September 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Any age

Performance status

  • Any

Life expectancy

  • More than 1 year


  • Not specified


  • Not specified


  • No history of hypercalcemia


Biologic therapy

  • Prior stem cell transplantation allowed
  • No concurrent hematopoietic growth factors


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00068276

United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Istvan Molnar, MD Wake Forest University Health Sciences
OverallOfficial: Bayard L. Powell, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00068276     History of Changes
Other Study ID Numbers: CCCWFU-29203
CDR0000318802 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: September 10, 2003
Last Updated: January 17, 2017

Keywords provided by Wake Forest University Health Sciences:
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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 21, 2017