Role in GVHD prophylaxis of Vitamin D in patients undergoing allogeneic transplantation of stem cells. Phase II Pilot Study

Phase 2

Not yet recruiting

• Conditions: haematologic condition who need staminal cells transplant

• Registration Number: 2024-518738-97-00
• Lead Sponsor: Azienda Ospedaliero Universitaria Pisana

Brief Summary

Evaluation of the effectiveness of vitamin D on the degree si severity of acute and chronic GvHD

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-19
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

• Patients aged > 18 years. Male and female - Diagnosis of any oncohematologic disease with transplant indication, also allowed patients not in clinical response - Patients undergoing allogeneic stem cell transplantation regardless of conditioning regimen and HSC source - Ability to sign informed consent

Exclusion Criteria

• Transplantation from T-depleted or T-selected product; - Documented intolerance to the drug or any of its excipients; - Ongoing vitamin D therapy for any medical condition; -Hypercalcemia, hypercalciuria, kidney stones, renal failure; - Age < 18 years - Subjects who are not deemed legally capable of consent. - In the case of female: sex pregnancy and/or lactation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reducing the severity of GVHD		Reducing the severity of GVHD

Secondary Outcome Measures

Name	Time	Method
- Evaluation of circulating lymphocyte subpopulations on peripheral blood - Assessment of vitamin D receptor (VDR) surface expression and modulation in response to vitamin D treatment on lymphocyte subpopulations. - Evaluation of the soluble fraction of VDR on serum - post hoc evaluation of the role of polymorphisms (SNPs) of recipient and donor VDR on response to vitamin D therapy - collection of any adverse events brought about by cholecalciferol intake		- Evaluation of circulating lymphocyte subpopulations on peripheral blood - Assessment of vitamin D receptor (VDR) surface expression and modulation in response to vitamin D treatment on lymphocyte subpopulations. - Evaluation of the soluble fraction of VDR on serum - post hoc evaluation of the role of polymorphisms (SNPs) of recipient and donor VDR on response to vitamin D therapy - collection of any adverse events brought about by cholecalciferol intake

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

Azienda Ospedaliero Universitaria Pisana

🇮🇹Pisa, Italy

Sara Galimberti

Site contact

050993488

sara.galimberti@unipi.it