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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.
Hematopoietic stem cell transplantation (HSCT) is an effective treatment strategy for many malignancies, marrow failure syndromes, and immune deficiencies in children, adolescents, and adults. Vitamin A and its derivatives regulate growth and differentiation of intestinal cells, and vitamin A deficiency is associated with increased susceptibility to infection in both human and animal models. The investigators' preliminary data suggest lower vitamin A levels were associated with an increased incidence of gastrointestinal graft versus host disease (GI GVHD) in patients undergoing HSCT.
This study is a randomized double blinded comparison of vitamin A supplementation comparing a single large dose of vitamin A with a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin A | Active Comparator | 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 | Placebo Comparator | Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of moderate-severe chronic graft versus host disease (GVHD) | Incidence of moderate-severe chronic GVHD | 1 year after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute gastrointestinal graft versus host disease (GI GVHD) | Incidence of acute GI GVHD | 2 years after transplant |
| Incidence of relapse | Incidence of relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celeste Dourson, MS, CCRP | Contact | 513-636-7679 | celeste.dourson@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Pooja Khandelwal, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D014802 | Vitamin A Deficiency |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Placebo | Other | Placebo pills containing microcrystalline cellulose will be dispensed in patients who are randomized to the placebo arm. |
|
| 2 years after transplant |
| Overall survival. | Overall survival. | 2 years after transplant |
| Roswell Park Comprehensive Cancer Center | Recruiting | Buffalo | New York | 14203 | United States |
|
| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
|
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |