Status:
COMPLETED
Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Vitamin D Deficiency
Hematopoietic Stem Cell Transplantation (HSCT)
Eligibility:
All Genders
Phase:
NA
Brief Summary
The investigators hypothesize that vitamin D levels can be improved in hematopoietic stem cell transplantation (HSCT) recipients not responding or tolerating standard enteral supplementation options b...
Detailed Description
The purpose of this study is to investigate efficacy of oral thin film (OTF) cholecalciferol (vitamin D3) replacement in hematopoietic stem cell transplantation (HSCT) recipients who failed to achieve...
Eligibility Criteria
Inclusion
- HSCT recipients of any age with vitamin D levels ≤35 ng/mL, or unable to tolerate, or refractory to enteral supplementation formulations of Vitamin D will be offered Vitamin D OTF.
Exclusion
- Subjects with 25OHD level \>60ng/mL. Subjects can be re-screened multiple times and enrolled later if they meet study criteria.
- Subjects with clinically significant and uncontrolled hypercalcemia as deemed by treating physician.
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04818957
Start Date
June 7 2021
End Date
April 20 2022
Last Update
March 2 2023
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229