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Role of Vitamin D in GVHD prophylaxis in patients undergoing allogeneic transplantation stem cells. Pilot phase II study randomized open monocentric

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518738-97-00
Acronym
D AGAINST GVH
Enrollment
20
Registered
2024-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

haematologic condition who need staminal cells transplant

Brief summary

Reducing the severity of GVHD

Detailed description

- 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

Interventions

DRUGTREDIMIN 25.000 U.I. /2
DRUG5 ml soluzione orale

Sponsors

Azienda Ospedaliero Universitaria Pisana
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Reducing the severity of GVHD

Secondary

MeasureTime frame
- 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

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026