NCT03202849

A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation

A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that supplementation with vitamins A and D will reduce the incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with supplementation with vitamin D alone.

Detailed description

The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) and they believe supplemental vitamin A at the time of hematopoietic stem cell transplantation (HSCT) can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). In addition, the investigators' preliminary data suggest that a significant number of patients requiring HSCT have vitamin D deficiency even prior to transplantation, and that persistent and newly developed deficiency post-HSCT resulted in worse outcomes. This study is a comparison of vitamin D supplementation comparing a single large dose of vitamin D "stoss therapy" with a placebo in the standard care arm with supplementation with single large doses of both vitamins D and A in the experimental arm. Participants will be randomly assigned to either the standard care arm or the experimental arm.

Conditions

• Hematopoietic Stem Cell Transplant

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D and A	A single dose of Vitamin A and Vitamin D will be given.
DIETARY_SUPPLEMENT	Vitamin D and Placebo	A single dose of Vitamin D plus a placebo will be given.

Timeline

• Start date: 2018-02-19
• Primary completion: 2022-08-14
• Completion: 2023-05-06
• First posted: 2017-06-29
• Last updated: 2023-05-12

Locations

1 site across 1 country: United States