Immunomodulatory Effect of Vitamin D in Allogenic Post-transplant

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

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