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The investigators hypothesize that supplementation with vitamins A and D will reduce the incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with supplementation with vitamin D alone.
The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) and they believe supplemental vitamin A at the time of hematopoietic stem cell transplantation (HSCT) can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). In addition, the investigators' preliminary data suggest that a significant number of patients requiring HSCT have vitamin D deficiency even prior to transplantation, and that persistent and newly developed deficiency post-HSCT resulted in worse outcomes.
This study is a comparison of vitamin D supplementation comparing a single large dose of vitamin D "stoss therapy" with a placebo in the standard care arm with supplementation with single large doses of both vitamins D and A in the experimental arm. Participants will be randomly assigned to either the standard care arm or the experimental arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D and A Supplementation | Experimental | Participants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT. |
|
| Vitamin D Supplementation with Placebo | Active Comparator | Participants receive a single dose of vitamin D and a single dose of placebo prior to HSCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D and A | Dietary Supplement | A single dose of Vitamin A and Vitamin D will be given. |
|
| Measure | Description | Time Frame |
|---|---|---|
| GI GVHD | Incidence of acute GI GVHD at day +100 after transplant. GVHD will be graded by the treating physician as per the modified Glucksberg criteria. | 100 days after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| MBI-LCBI | Incidence of MBI-LCBI at day +100 after transplant. | 100 days after transplant |
| Treatment Related Mortality | Treatment related mortality at day +100 after transplant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stella Davies, MBBS, PhD, MRCP | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38227933 | Derived | Khandelwal P, Langenberg L, Luebbering N, Lake KE, Butcher A, Bota K, Ramos KN, Taggart C, Choe H, Vasu S, Teusink-Cross A, Koo J, Wallace G, Romick-Rosendale L, Watanabe-Chailland M, Haslam DB, Lane A, Davies SM. A randomized phase 2 trial of oral vitamin A for graft-versus-host disease in children and young adults. Blood. 2024 Mar 21;143(12):1181-1192. doi: 10.1182/blood.2023022865. |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Vitamin D and Placebo | Dietary Supplement | A single dose of Vitamin D plus a placebo will be given. |
|
| 100 days after transplant |
| Overall Survival | Overall survival at 1 year after transplant. | 1 year after transplant |