NCT06450925

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Graft Vs Host Disease
• Vitamin A Deficiency
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Vitamin A	Enrolled subjects will receive one observed oral vitamin A dose, prior to their HSCT, in the outpatient clinic or inpatient Bone Marrow Transplant (BMT) floor.
OTHER	Placebo	Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.

Timeline

• Start date: 2025-03-25
• Primary completion: 2027-08-01
• Completion: 2029-08-01
• First posted: 2024-06-10
• Last updated: 2025-08-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study