Study on the Role of Vitamin D (Colecalciferol) in Preventing Graft-Versus-Host Disease in Patients Undergoing Stem Cell Transplantation

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What is this study about?

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.

1 joining the study

Participation begins after meeting the inclusion criteria, which include being over 18 years old, having a diagnosis of a blood-related condition requiring a stem cell transplant, and the ability to provide informed consent.

2 initial assessment

An initial assessment is conducted to evaluate the current health status and eligibility for the study. This includes reviewing medical history and conducting necessary tests.

3 treatment with vitamin D

The treatment involves taking an oral solution called TREDIMIN 25.000 U.I. /2.5 ml, which contains colecalciferol (vitamin D). The dosage and frequency of administration are determined by the study protocol and are aimed at reducing the severity of graft-versus-host disease (GVHD).

4 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment. This includes evaluating the severity of GVHD, analyzing blood samples for lymphocyte subpopulations, and assessing vitamin D receptor expression.

Any side effects or adverse events related to the intake of colecalciferol are recorded and evaluated.

5 completion of the study

The study is expected to conclude by December 2027. Upon completion, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Patients must be older than 18 years. This includes both men and women.
Patients must have a diagnosis of any oncohematologic disease. This means a type of cancer that affects the blood, bone marrow, or lymph nodes, and they must need a transplant.
Patients can participate even if their disease is not responding to treatment.
Patients must be undergoing an allogeneic stem cell transplantation. This is a procedure where a patient receives stem cells from a donor.
Patients must be able to sign an informed consent. This means they understand the study and agree to participate.

Who Cannot Join the Study?

Patients who have a blood-related condition that requires a stem cell transplant cannot participate. A stem cell transplant is a procedure where healthy cells are used to replace damaged or diseased cells in the body.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universita’ Di Pisa	Pisa	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.12.2024

Trial locations

Investigated drugs:

Colecalciferol

Vitamin D is being studied for its potential role in preventing graft-versus-host disease (GVHD) in patients who are undergoing stem cell transplants. The trial aims to evaluate how effective Vitamin D is in reducing the severity of both acute and chronic forms of GVHD.

Graft-versus-host disease (GVHD) – This condition occurs when donor stem cells attack the recipient’s body after a stem cell transplant. It can be classified into acute and chronic forms. Acute GVHD typically develops within the first 100 days post-transplant and primarily affects the skin, liver, and gastrointestinal tract. Chronic GVHD can occur later and may involve multiple organs, leading to symptoms such as skin rashes, dry eyes, and joint pain. The severity of GVHD can vary, with some cases being mild and others more severe. The condition is a significant complication of stem cell transplantation, requiring careful management.

Trial ID:

2024-518738-97-00

Protocol code:

D AGAINST GVH

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Role of Vitamin D (Colecalciferol) in Preventing Graft-Versus-Host Disease in Patients Undergoing Stem Cell Transplantation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?