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Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

ConditionsGraft Vs Host DiseaseVitamin A DeficiencyVitamin D Deficiency
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be 18 years of age or older

Be scheduled for allogeneic stem cell transplant.

Have a vitamin A level < upper limit of normal for age.

Be able to tolerate enteral vitamin dose administration.

Disqualifiers

Ongoing raised intracranial pressure (see appendix D for definition of raised intracranial pressure)

Liver cirrhosis (see appendix C for definition of liver cirrhosis)

Patients will be excluded if they are currently pregnant.

Patients will be excluded if they have a fish (not shellfish) allergy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin A

    Drug

    Enrolled subjects will receive one observed oral vitamin A dose, prior to their HSCT, in the outpatient clinic or inpatient Bone Marrow Transplant (BMT) floor.

  • Placebo

    Other intervention

    Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Vitamin AActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of moderate-severe chronic graft versus host disease (GVHD)

Incidence of moderate-severe chronic GVHD

Time frame
1 year after transplant

Secondary outcomes

1

Incidence of acute gastrointestinal graft versus host disease (GI GVHD)

Incidence of acute GI GVHD

Time frame
2 years after transplant
2

Incidence of relapse

Incidence of relapse

Time frame
2 years after transplant
3

Overall survival.

Overall survival.

Time frame
2 years after transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Source ClinicalTrials.gov
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