Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates
NCT ID: NCT03039257
Last Updated: 2018-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2017-02-02
2018-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vitamin A
Participants receive single dose vitamin A supplementation prior to HSCT. A 3x3 dose escalation/de-escalation design will be used for this study.
Vitamin A
Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.
Interventions
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Vitamin A
Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
1 Year
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Stella Davies, MBBS, PhD, MRCP
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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2016-5937
Identifier Type: -
Identifier Source: org_study_id
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