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

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Hematopoietic Stem Cell Transplant

Treatments

Dietary Supplement: Vitamin A

Study type

Interventional

Funder types

Other

Identifiers

NCT03039257

2016-5937

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion criteria

Any patient undergoing HSCT.

Exclusion criteria

Vitamin A hypersensitivity or allergy.
Age less than 1 year at time of transplant.
Baseline pre-HSCT vitamin A levels higher than the upper quartile of normal range for age.
Enteral feeding or medication intolerance.
Pregnancy.