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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03039257

Enrollment

Registered

2017-02-01

Start date

2017-02-02

Completion date

2018-03-28

Last updated

2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Transplant

Keywords

hematopoietic stem cell transplant, vitamin a

Brief 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.

Interventions

DIETARY_SUPPLEMENTVitamin A

Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Vitamin A Level	30 days after HSCT	Vitamin A level will be measured 30 days after HSCT.

Secondary

Measure	Time frame	Description
Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI)	100 days after HSCT	Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) 100 days after HSCT.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026