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Clinical Trial Summary

The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.


Clinical Trial Description

Hematopoietic stem cell transplantation (HSCT) is an effective treatment strategy for many malignancies, marrow failure syndromes, and immune deficiencies in children, adolescents, and adults. Vitamin A and its derivatives regulate growth and differentiation of intestinal cells, and vitamin A deficiency is associated with increased susceptibility to infection in both human and animal models. The investigators' preliminary data suggest lower vitamin A levels were associated with an increased incidence of gastrointestinal graft versus host disease (GI GVHD) in patients undergoing HSCT. This study is a randomized double blinded comparison of vitamin A supplementation comparing a single large dose of vitamin A with a placebo. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06450925
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact Celeste Dourson, MS, CCRP
Phone 513-636-7679
Email celeste.dourson@cchmc.org
Status Not yet recruiting
Phase N/A
Start date October 2024
Completion date August 2029

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