Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450925
• Other study ID #: 2023-0301
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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