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Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates

Hematopoietic Stem Cell Transplant Clinical Trial

Official title:
Single, High Dose Vitamin A Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation and Its Role on MBI-LCBI Rates

Clinical Trial Summary

The primary objective of this study is to establish that single dose vitamin A supplementation is feasible and safe in pediatric and young adult bone marrow transplant recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.

Clinical Trial Description

The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI), likely via decreased gut permeability, and they hypothesize supplemental vitamin A at the time of HSCT can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). A 3x3 dose escalation/de-escalation study design will be used to determine the safety and dosing required to maintain vitamin A levels in the upper quartile of normal range for age at day +30 (± 7 days) with single dose vitamin A supplementation prior to hematopoietic stem cell transplantation. ;

Study Design

Related Conditions & MeSH terms

  • Hematopoietic Stem Cell Transplant
Clinical Trial Details
NCT number NCT03039257
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact
Status Completed
Phase N/A
Start date February 2, 2017
Completion date March 28, 2018
View Details
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