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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 6, 2022

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 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.

Arms, Groups and Cohorts

  • Experimental: Vitamin D Oral Thin Film (OTF)
    • Study subjects will receive vitamin D OTF for a maximum of 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Vitamin D Level
    • Time Frame: 12 weeks from starting vitamin D supplementation
    • Number of participants who achieve 25OH vitamin D level >35ng/mL

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital Medical Center, Cincinnati
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Allison Bartlett, MD, Principal Investigator, Children’s Hospital Medical Center, Cincinnati
    • Gregory Wallace, DO, Principal Investigator, Children’s Hospital Medical Center, Cincinnati

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