Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 26, 2021
CompletedStudy Start
First participant enrolled
June 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2022
CompletedMarch 2, 2023
March 1, 2023
10 months
March 24, 2021
March 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Vitamin D Level
Number of participants who achieve 25OH vitamin D level \>35ng/mL
12 weeks from starting vitamin D supplementation
Study Arms (1)
Vitamin D Oral Thin Film (OTF)
EXPERIMENTALStudy subjects will receive vitamin D OTF for a maximum of 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (1)
Bartlett AL, Zhang G, Wallace G, McLean S, Myers KC, Teusink-Cross A, Taggart C, Patel B, Davidson R, Davies SM, Jodele S. Optimized vitamin D repletion with oral thin film cholecalciferol in patients undergoing stem cell transplant. Blood Adv. 2023 Aug 22;7(16):4555-4562. doi: 10.1182/bloodadvances.2023009855.
PMID: 37285801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Bartlett, MD
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Gregory Wallace, DO
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2021
First Posted
March 26, 2021
Study Start
June 7, 2021
Primary Completion
April 6, 2022
Study Completion
April 20, 2022
Last Updated
March 2, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share