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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2022-04-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitamin D Deficiency Hematopoietic Stem Cell Transplantation (HSCT)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D Oral Thin Film (OTF)

Study subjects will receive vitamin D OTF for a maximum of 12 weeks.

Group Type EXPERIMENTAL

Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No