Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450925
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
Vitamin A Supplementation in Allogeneic Stem Cell Transplantation
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
This study is a randomized double blinded comparison of vitamin A supplementation comparing a single large dose of vitamin A with a placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None