Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Part of paid clinical trials in Tampa, Florida.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06450925
Phase
PHASE2
Status
Recruiting
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Conditions

  • Graft Vs Host Disease
  • Vitamin A Deficiency
  • Vitamin D Deficiency

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 25, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2029

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Vitamin A
    Route of administration: Oral. Frequency: Once. Timing: Pre-transplant Dose of Vit A: 1.2 mg/kg, max dose 75 mg Formulation of Vit A: 2.5 mg liquid filled oral capsules. Vitamin A level assessment: Vitamin A levels will be measured pre-transplant and again at day +30 (± 10 days)
  • Placebo Comparator: Placebo
    Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm.

Primary Outcome Measure

Incidence of moderate-severe chronic graft versus host disease (GVHD) [ Time Frame: 1 year after transplant ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Nelli Bejanyan, MD (PRINCIPAL_INVESTIGATOR)
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203
Theresa Hahn, PhD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Sumithira Vasu, MD (PRINCIPAL_INVESTIGATOR)

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