A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 in Pediatric Patients Undergoing HSCT
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Cancer, Other Indications, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Anemia, Anemia, Gastrointestinal, Hematology, Hematology, Hematology |
| Therapuetic Areas: | Gastroenterology, Hematology, Oncology, Other |
| Healthy: | No |
| Age Range: | 1 - 25 |
| Updated: | 12/14/2018 |
| Start Date: | November 1, 2017 |
| End Date: | September 1, 2019 |
A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 (Stoss Therapy) in Pediatric Patients Undergoing HSCT to Prevent Vitamin D Deficiency and Insufficiency During Transplant
Research has suggested that children with sufficient vitamin D levels undergoing
hematopoietic stem cell transplant (HSCT) have improved outcomes, including lower incidences
of infection and graft-versus-host disease (GVHD), as well as overall improved survival.
However, supplementation in children undergoing HSCT has shown to be a challenge using
standard or aggressive supplementation strategies. The primary objective of this study is to
determine the safety and efficacy of a single, high dose oral vitamin D (Stoss Therapy) at
the start of transplant followed by maintenance supplementation in children undergoing HSCT.
hematopoietic stem cell transplant (HSCT) have improved outcomes, including lower incidences
of infection and graft-versus-host disease (GVHD), as well as overall improved survival.
However, supplementation in children undergoing HSCT has shown to be a challenge using
standard or aggressive supplementation strategies. The primary objective of this study is to
determine the safety and efficacy of a single, high dose oral vitamin D (Stoss Therapy) at
the start of transplant followed by maintenance supplementation in children undergoing HSCT.
Comorbidities and complications including infection, organ system toxicity, graft-versus-host
disease (GVHD) and disease recurrence are some of the biggest contributors to quality of life
and mortality in children undergoing hematopoietic stem cell transplant (HSCT). Research has
suggested that patients with sufficient vitamin D levels during transplant have improved
outcomes, including lower incidences of infection and acute GVHD, as well as overall improved
survival. Prior research has shown that chronically ill children are at risk for vitamin D
deficiency, including those undergoing HSCT. Data has shown populations with as many as 70%
of HSCT patients have insufficient levels of vitamin D at time of transplant. While several
studies have attempted methods of vitamin D supplementation in this subset of patients, there
has not been success with either standard or aggressive supplementation strategies.
Single high-dose oral vitamin D therapy, known as stoss therapy, has been used in other
chronically ill children where adequate levels of vitamin D are difficult to attain. Stoss
therapy suggests a single high-dose followed by maintenance dosing would be adequate to
replete and maintain vitamin D levels in chronically ill children. While it has been shown to
be effective with no evidence of toxicity in patients with rickets and cystic fibrosis, its
safety and efficacy has not been studied in the transplant setting. However, there is an
urgent need to identify a modifiable factor may reduce the occurrence and/or severity of HSCT
associated complications. The overall objective of this study is to determine the
effectiveness of a single, high dose oral vitamin D (Stoss Therapy) followed by maintenance
supplementation in children undergoing HSCT. This change will result in a new and innovative
approach to maintaining adequate vitamin D levels during pediatric HSCT, with the long term
goal of reducing morbidity and mortality.
Our primary goal is to assess the safety and efficacy of a single, high dose of vitamin D
followed by maintenance supplementation in children undergoing HSCT. Our secondary goal is to
identify the effects of adequate vitamin D levels on early clinical outcomes such as cytokine
levels, graft versus host disease, immune recovery, rejection, relapse, infection rates in
pediatric HSCT patients.
disease (GVHD) and disease recurrence are some of the biggest contributors to quality of life
and mortality in children undergoing hematopoietic stem cell transplant (HSCT). Research has
suggested that patients with sufficient vitamin D levels during transplant have improved
outcomes, including lower incidences of infection and acute GVHD, as well as overall improved
survival. Prior research has shown that chronically ill children are at risk for vitamin D
deficiency, including those undergoing HSCT. Data has shown populations with as many as 70%
of HSCT patients have insufficient levels of vitamin D at time of transplant. While several
studies have attempted methods of vitamin D supplementation in this subset of patients, there
has not been success with either standard or aggressive supplementation strategies.
Single high-dose oral vitamin D therapy, known as stoss therapy, has been used in other
chronically ill children where adequate levels of vitamin D are difficult to attain. Stoss
therapy suggests a single high-dose followed by maintenance dosing would be adequate to
replete and maintain vitamin D levels in chronically ill children. While it has been shown to
be effective with no evidence of toxicity in patients with rickets and cystic fibrosis, its
safety and efficacy has not been studied in the transplant setting. However, there is an
urgent need to identify a modifiable factor may reduce the occurrence and/or severity of HSCT
associated complications. The overall objective of this study is to determine the
effectiveness of a single, high dose oral vitamin D (Stoss Therapy) followed by maintenance
supplementation in children undergoing HSCT. This change will result in a new and innovative
approach to maintaining adequate vitamin D levels during pediatric HSCT, with the long term
goal of reducing morbidity and mortality.
Our primary goal is to assess the safety and efficacy of a single, high dose of vitamin D
followed by maintenance supplementation in children undergoing HSCT. Our secondary goal is to
identify the effects of adequate vitamin D levels on early clinical outcomes such as cytokine
levels, graft versus host disease, immune recovery, rejection, relapse, infection rates in
pediatric HSCT patients.
Inclusion Criteria:
- All pediatric patients, ages 1 to 25 years of age, undergoing hematopoietic stem cell
transplant at Phoenix Children's hospital
- Patients must sign an informed consent
Exclusion Criteria:
- Prior rejection of hematopoietic stem cell transplant
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