Study on the Role of Vitamin D (Colecalciferol) in Preventing Graft-Versus-Host Disease in Patients Undergoing Stem Cell Transplantation
This clinical trial is investigating whether Vitamin D can help prevent a serious complication called graft-versus-host disease in patients receiving stem cell transplants for blood-related conditions. The study is taking place in Italy and is expected to continue until December 2027.
Main focus: The trial aims to evaluate how effective Vitamin D supplementation is in reducing the severity of graft-versus-host disease, which occurs when donor stem cells attack the recipient's body after a transplant. Graft-versus-host disease can develop in two forms: acute, which typically appears within the first 100 days after transplant and mainly affects the skin, liver, and digestive system; and chronic, which can occur later and may involve multiple organs, causing symptoms like skin rashes, dry eyes, and joint pain.
Investigational drug: The study uses an oral solution called TREDIMIN 25,000 U.I., which contains colecalciferol, a form of Vitamin D. While Vitamin D is well-known for supporting bone health, researchers are exploring its ability to modulate the immune system and potentially reduce the inflammation and immune response that lead to graft-versus-host disease.
Who can participate: The trial is open to adults over 18 years of age, both men and women, who have been diagnosed with any type of cancer affecting the blood, bone marrow, or lymph nodes and require an allogeneic stem cell transplantation. This type of transplant involves receiving stem cells from a donor. Patients can participate even if their disease is not responding to treatment, as long as they are able to understand the study and provide informed consent.
Who cannot participate: The exclusion criteria indicate that patients who have a blood-related condition requiring a stem cell transplant cannot participate, though this appears to contradict the inclusion criteria and may reflect specific circumstances that would be clarified during the screening process.
What happens during the study: Participants will receive either the Vitamin D treatment or a placebo. Throughout the study period, regular monitoring will be conducted to assess the effectiveness of the treatment by evaluating the severity of graft-versus-host disease and analyzing blood samples to examine specific immune cells. The study will also track how Vitamin D interacts with certain proteins on these immune cells and document any side effects that may occur from taking the supplement.
Italy