Immunomodulatory Effect of Vitamin D in Allogenic Post-transplant
Alovita-1
1 other identifier
interventional
150
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2011
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 10, 2015
CompletedNovember 10, 2015
November 1, 2015
3.8 years
June 9, 2015
November 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence/severity of Graft-Versus-Host-Disease
Number of cases of GVHD/Seriousness graded according to National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease
Day +150 post-transplant
Secondary Outcomes (9)
Serum levels of Th1/Th2 cytokines
Day -5 pre-transplant and +1, +7, +21,+56 and +100 post-transplant
Dendritic cells
Day +21,+56 and +100 post-transplant
Subpopulations of lymphocytes
Day +21,+56 and +100 post-transplant
Regulatory T cells
Day +21,+56 and +100 post-transplant
NK markers
Day +21,+56 and +100 post-transplant
- +4 more secondary outcomes
Study Arms (3)
Group 1: Control
NO INTERVENTIONControl 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 2: 1000IU/day of Vitamine D
EXPERIMENTALIt is composed by the following 50 patients joining the study. They will take 1000 IU of vitamin D once a day.
Group 3: 5000IU/day of Vitamine D
EXPERIMENTALIt is composed by the last 50 patients joining the study. They will take 5000 IU of vitamin D once a day.
Interventions
Administration of a specified dose of Vitamine D
Administration of a specified dose of Vitamine D
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Christelle Ferrà i Coll
Badalona, Barcelona, Spain
Carmen Martínez
Barcelona, Barcelona, Spain
David Valcárcel Ferreiras
Barcelona, Barcelona, Spain
Raquel Saldaña Moreno
Jerez de la Frontera, Cádiz, Spain
Manuel Jurado Chacón
Granada, Granada, Spain
Mª Ángeles Cuesta
Málaga, Málaga, Spain
Fermín Martín Sánchez- Guijo
Salamanca, Salamanca, Spain
Related Publications (2)
Carrillo-Cruz E, Garcia-Lozano JR, Marquez-Malaver FJ, Sanchez-Guijo FM, Montero Cuadrado I, Ferra I Coll C, Valcarcel D, Lopez-Godino O, Cuesta M, Parody R, Lopez-Corral L, Alcoceba M, Caballero-Velazquez T, Rodriguez-Gil A, Bejarano-Garcia JA, Ramos TL, Perez-Simon JA. Vitamin D Modifies the Incidence of Graft-versus-Host Disease after Allogeneic Stem Cell Transplantation Depending on the Vitamin D Receptor (VDR) Polymorphisms. Clin Cancer Res. 2019 Aug 1;25(15):4616-4623. doi: 10.1158/1078-0432.CCR-18-3875. Epub 2019 May 1.
PMID: 31043390DERIVEDCaballero-Velazquez T, Montero I, Sanchez-Guijo F, Parody R, Saldana R, Valcarcel D, Lopez-Godino O, Ferra I Coll C, Cuesta M, Carrillo-Vico A, Sanchez-Abarca LI, Lopez-Corral L, Marquez-Malaver FJ, Perez-Simon JA; GETH (Grupo Espanol de Trasplante Hematopoyetico). Immunomodulatory Effect of Vitamin D after Allogeneic Stem Cell Transplantation: Results of a Prospective Multicenter Clinical Trial. Clin Cancer Res. 2016 Dec 1;22(23):5673-5681. doi: 10.1158/1078-0432.CCR-16-0238. Epub 2016 Jun 29.
PMID: 27358490DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
José Antonio Pérez-Simón, MD-PhD
Head of haematology department
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
November 10, 2015
Study Start
July 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
November 10, 2015
Record last verified: 2015-11