Vitamin A Replacement in Patients Undergoing HSCT and Its... | NCT03039257

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

NCT03039257

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Hematopoietic Stem Cell Transplant

Interventions

Vitamin A

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2017Actual

Primary Completion Date

Jan 17, 2018Actual

Completion Date

Mar 28, 2018Actual

First Submitted Date

Jan 31, 2017

First Submission Date that Met QC Criteria

Jan 31, 2017

First Posted Date

Feb 1, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2018

Last Update Posted Date

May 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vitamin A	Dietary Supplement	Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.	Vitamin A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stella Davies, MBBS, PhD, MRCP	Children's Hospital Medical Center, Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45229	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014801	Vitamin A

Ancestor Terms

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839

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