Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial
Sponsor: National Cancer Institute (NCI)
Listed as NCT00068276, this PHASE2 trial focuses on Leukemia and Myelodysplastic Syndromes and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 7 times since 2003, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Sep 2018 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
-
Jun 2018 — Sep 2018 [monthly]
Completed PHASE2
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Jul 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Cancer Institute (NCI)
- Wake Forest University Health Sciences
For direct contact, visit the study record on ClinicalTrials.gov .