Role of Vitamin D in patients undergoing allogeneic stem cell transplantation. Pilot study

Role of Vitamin D in GVHD prophylaxis in patients undergoing allogeneic stem cell transplantation. Randomized single-center pilot study - -

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003994-23-IT

Enrollment

Registered

2021-06-04

Start date

2021-09-09

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

Treatment of acute and chronic graft versus host disease (GVHD) after allogeneic donor hematopoietic stem cell transplantation in adult patients with haematological diseases. MedDRA version: 20.0 Level: LLT Classification code 10068908 Term: AGVHD System Organ Class: 100000004870

Interventions

Trade Name: TREDIMIN Product Name: TREDIMIN Product Code: [042753121] Pharmaceutical Form: Oral drops INN or Proposed INN: COLECALCIFEROLO Current Sponsor code: NA Other descriptive name: vitamina D3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age > 18 years old - Diagnosis of any oncohematological pathology with transplant indication; patients not in clinical response allowed - Patients undergoing allogeneic stem cell transplantation regardless of the conditioning regimen and source of CSE - ability to sign informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: - Transplant from T-depleted or T-selected product - Documented intolerance to the drug or to one of its excipients; - Ongoing vitamin D therapy for any medical conditions; - Hypercalcemia, hypercalciuria, kidney stones, renal failure; - age < 18 years - Subjects who are not legally deemed capable of understanding and willing.

Design outcomes

Primary

Measure	Time frame
Main Objective: Reduction in the severity of acute and chronic GvHD in patients treated with Vitamin D compared to the control group;Secondary Objective: Evaluation of lymphocyte subsets circulating on peripheral blood Evaluation of the surface expression of the vitamin D receptor (VDR) and modulation in response to treatment with vitamin D on lymphocyte subpopulations Evaluation of the soluble fraction of the VDR on serum Post hoc evaluation of the role of polymorphisms (SNPs) of the recipient and donor VDR on the response to vitamin D therapy;Primary end point(s): Evaluate the effectiveness of vitamin D in GVHD in terms of presentation and severity.;Timepoint(s) of evaluation of this end point: 18 months	—

Measure

Time frame

Main Objective: Reduction in the severity of acute and chronic GvHD in patients treated with Vitamin D compared to the control group;Secondary Objective: Evaluation of lymphocyte subsets circulating on peripheral blood Evaluation of the surface expression of the vitamin D receptor (VDR) and modulation in response to treatment with vitamin D on lymphocyte subpopulations Evaluation of the soluble fraction of the VDR on serum Post hoc evaluation of the role of polymorphisms (SNPs) of the recipient and donor VDR on the response to vitamin D therapy;Primary end point(s): Evaluate the effectiveness of vitamin D in GVHD in terms of presentation and severity.;Timepoint(s) of evaluation of this end point: 18 months

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Secondary

Measure	Time frame
Secondary end point(s): - Evaluation of lymphocyte subsets circulating on peripheral blood - Evaluation of the surface expression of the vitamin D receptor (VDR) and modulation in response to treatment with vitamin D on lymphocyte subpopulations. - Evaluation of the soluble fraction of VDR on serum - Post hoc evaluation of the role of polymorphisms (SNPs) of the recipient and donor VDR on the response to vitamin D therapy;Timepoint(s) of evaluation of this end point: 18 mesi	—

Measure

Time frame

Secondary end point(s): - Evaluation of lymphocyte subsets circulating on peripheral blood - Evaluation of the surface expression of the vitamin D receptor (VDR) and modulation in response to treatment with vitamin D on lymphocyte subpopulations. - Evaluation of the soluble fraction of VDR on serum - Post hoc evaluation of the role of polymorphisms (SNPs) of the recipient and donor VDR on the response to vitamin D therapy;Timepoint(s) of evaluation of this end point: 18 mesi

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Countries

Italy

Contacts

Public ContactU.O. Ematologia Univ

Azienda Ospedaliero Universitaria Pisana

mario.petrini@ao-pisa.toscana.it050993488

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026