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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06450925
Other study ID # 2023-0301
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2024
Est. completion date August 2029

Study information

Verified date June 2024
Source Children's Hospital Medical Center, Cincinnati
Contact Celeste Dourson, MS, CCRP
Phone 513-636-7679
Email celeste.dourson@cchmc.org
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 190
Est. completion date August 2029
Est. primary completion date August 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Be scheduled for allogeneic stem cell transplant. - Have a vitamin A level < upper limit of normal for age. - Be able to tolerate enteral vitamin dose administration. - Have a total bilirubin level < 1.5x ULN and an AST and/or ALT< 3xULN for age Exclusion Criteria: - History of ongoing raised intracranial pressure - History of pregnancy - History of liver cirrhosis

Study Design


Intervention

Dietary Supplement:
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 vegetable oil with lactose powder as a filler will be dispensed in patients who are randomized to the placebo arm.

Locations

Country Name City State
United States Roswell Park Comprehensive Cancer Center Buffalo New York
United States The Ohio State University Columbus Ohio
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of moderate-severe chronic graft versus host disease (GVHD) Incidence of moderate-severe chronic GVHD 1 year after transplant
Secondary Incidence of acute gastrointestinal graft versus host disease (GI GVHD) Incidence of acute GI GVHD 2 years after transplant
Secondary Incidence of relapse Incidence of relapse 2 years after transplant
Secondary Overall survival. Overall survival. 2 years after transplant
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