NCT03039257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

January 31, 2017

Last Update Submit

May 29, 2018

Conditions

Hematopoietic Stem Cell Transplant

Keywords

hematopoietic stem cell transplantvitamin a

Outcome Measures

Primary Outcomes (1)

  • Vitamin A Level

    Vitamin A level will be measured 30 days after HSCT.

    30 days after HSCT

Secondary Outcomes (1)

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

    100 days after HSCT

Study Arms (1)

Vitamin A

OTHER

Participants receive single dose vitamin A supplementation prior to HSCT. A 3x3 dose escalation/de-escalation design will be used for this study.

Dietary Supplement: Vitamin A

Interventions

Vitamin ADIETARY_SUPPLEMENT

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

Vitamin A

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing HSCT.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

Vitamin A

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Stella Davies, MBBS, PhD, MRCP

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 1, 2017

Study Start

February 2, 2017

Primary Completion

January 17, 2018

Study Completion

March 28, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)