Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 1 - Any |
| Updated: | 6/1/2018 |
| Start Date: | February 2, 2017 |
| End Date: | March 28, 2018 |
Single, High Dose Vitamin A Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation 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.
supplementation is feasible and safe in pediatric and young adult bone marrow transplant
recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.
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.
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.
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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Stella Davies, MBBS, PhD, MRCP
Phone: 513-636-4379
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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