Universita' Di Pisa
Pisa, Italy
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the role of Vitamin D in preventing a condition called Graft-versus-Host Disease (GVHD) in patients who are undergoing a type of treatment known as allogeneic stem cell transplantation. This treatment is often used for patients with certain blood-related diseases that require a transplant of stem cells, which are special cells that can develop into different types of blood cells. The study will use a form of Vitamin D called colecalciferol, which is administered as an oral solution known as TREDIMIN 25,000 U.I.
The purpose of the study is to evaluate how effective Vitamin D is in reducing the severity of both acute and chronic forms of GVHD. Participants in the study will receive either the Vitamin D treatment or a placebo. The study will monitor the participants over a period of time to observe any changes in the severity of GVHD and to assess the impact of Vitamin D on certain immune cells in the blood. Additionally, the study will look at how Vitamin D interacts with specific proteins on these immune cells and will collect information on any side effects that may occur from taking colecalciferol.
This study is designed to gather important information that could help improve the care of patients undergoing stem cell transplants by potentially reducing the risk or severity of GVHD. The findings from this study may contribute to better understanding and management of this condition in the future.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
1 criterion
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Pisa, Italy
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