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NCT03039257 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT03039257
Other study ID # 2016-5937
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2017
Est. completion date March 28, 2018

Study information
Verified date May 2018
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date March 28, 2018
Est. primary completion date January 17, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

  • Hematopoietic Stem Cell Transplant

Intervention

Dietary Supplement:
• Vitamin A
Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vitamin A Level Vitamin A level will be measured 30 days after HSCT. 30 days after HSCT
Secondary Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) 100 days after HSCT. 100 days after HSCT
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