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Completed

NCT Number: NCT03039257

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

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplant

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin A

Dietary Supplement

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

Primary outcomes

  1. Vitamin A Level

    Time frame: 30 days after HSCT

    Vitamin A level will be measured 30 days after HSCT.

Secondary outcomes

  1. Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI)

    Time frame: 100 days after HSCT

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2017
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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