Hematopoietic Stem Cell Transplantation (HSCT), Vitamin D Deficiency
Conditions
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 by using vitamin D oral thin film (OTF) administration.
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 or sustain adequate vitamin D levels after vitamin D supplementation using current standard of care, or those unable to take/tolerate currently available enteral vitamin D formulations. With oral thin film (OTF) cholecalciferol, investigators hope to significantly improve the ease of administration, restoring compliance and facilitating therapeutic vitamin D levels without relying on the gut for absorption.
Interventions
DIETARY_SUPPLEMENTOral Thin Film (OTF) Cholecalciferol (Vitamin D3)
Study participants will receive vitamin D OTF weekly for a maximum of 12 weeks. The dose may be increased or decreased based on the dosing schema.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D Level | 12 weeks from starting vitamin D supplementation | Number of participants who achieve 25OH vitamin D level \>35ng/mL |
Countries
United States
Outcome results
None listed