Immunomodulatory Effect of Vitamin D in Allogenic Post-transplant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether vitamin D is effective in the prevention of graft-versus-host-disease after completion of allogeneic transplant.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation

NCT03202849

Hematopoietic Stem Cell Transplant

COMPLETED NA

High Dose Vitamin D Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT02876822

Vitamin D Deficiency

TERMINATED NA

Ultra-high Dose Vitamin D for HSCT

NCT03759262

Hematopoietic Stem Cell Transplant

COMPLETED PHASE1

Vitamin D on Prevention and Treatment of COVID-19

NCT04334005

Patients Infected With COVID-19

UNKNOWN NA

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

NCT06450925

Graft Vs Host Disease Vitamin A Deficiency Vitamin D Deficiency

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The allogeneic transplant of haematopoietic cell is the only treatment option for many malignant blood diseases. Unfortunately, the progression free survival and the quality of life of transplanted patients is limited due to the development of graft-versus-host-disease (GVHD).

The development of new prophylaxis strategies of GVHD based in the use of immunomodulator agents (allowing the generation of an immunotolerance state and avoiding the use of immunosuppression) is essential.

The GVHD is due to the cytotoxic effect of the donor lymphocytes T against healthy organs and tissues of the receptor. Calcineurin inhibitor combined with methotrexate or antibodies anti-lymphocytes T are used as standard prophylaxis. This type of antibodies has demonstrated efficacy to reduce GVHD, but have not increased survival due to increasing the risk of relapses and serious post-transplant infections.

Due to its interactions with VDR (vitamin D receptor) present in immune system cells, vitamin D is able to inhibit the activation of dendritic cells and the proliferation and production of cytokines by lymphocytes T. Based on this effect, the peri- and post- transplant administration of vitamin D might decrease the risk of GVHD in allogeneic transplanted patients, subsequently decreasing the immunosuppressant treatment requirements and improving the prognosis of those patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hematopoietic Stem Cell Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Control

Control group is composed by the first 50 patients included in the study. Those patients will not receive the treatment. Evaluations and follow-up will be the same as in the other groups.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2: 1000IU/day of Vitamine D

It is composed by the following 50 patients joining the study. They will take 1000 IU of vitamin D once a day.

Group Type EXPERIMENTAL

1000IU/day of Vitamine D

Intervention Type DRUG

Administration of a specified dose of Vitamine D

Group 3: 5000IU/day of Vitamine D

It is composed by the last 50 patients joining the study. They will take 5000 IU of vitamin D once a day.

Group Type EXPERIMENTAL

5000IU/day of Vitamine D

Intervention Type DRUG

Administration of a specified dose of Vitamine D

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

1000IU/day of Vitamine D

Administration of a specified dose of Vitamine D

Intervention Type DRUG

5000IU/day of Vitamine D

Administration of a specified dose of Vitamine D

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vitamine D dose of 1000 international units (IU) Vitamine D dose of 5000 international units (IU)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 years
* The patient should accomplish all the criteria to proceed to an allogeneic transplant
* The patient or their legal guardians should signed the informed consent approved by the Ethics Committees of Clinical Trials

Exclusion Criteria

* Hypercalcemia ≥ 10.5 mg/dl
* Renal insufficiency with creatinine level ≥ 2 x upper limit of normal (1,1 mg/dl)
* Participation in others Clinical Trials in which the intervention may affect the result of the study.
* Patients receiving GVHD immunoprophylaxis with thymoglobuline or GVHD prophylaxis including in vitro or in vivo lymphocytes T depletion (anti-lymphocyte T globulin, ALG)
* Patients receiving a transplant from an haploidentical donor

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No