NCT03039257

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hematopoietic Stem Cell Transplant

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin A	Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.

Timeline

• Start date: 2017-02-02
• Primary completion: 2018-01-17
• Completion: 2018-03-28
• First posted: 2017-02-01
• Last updated: 2018-05-30

Locations

1 site across 1 country: United States