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NCT04818957 Clinical Trial

Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation

Vitamin D Deficiency Clinical Trial

Official title:
Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04818957
Other study ID # 2021-0151
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2021
Est. completion date April 20, 2022

Study information
Verified date March 2023
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 20, 2022
Est. primary completion date April 6, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oral 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.

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vitamin D Level Number of participants who achieve 25OH vitamin D level >35ng/mL 12 weeks from starting vitamin D supplementation
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