A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 in Pediatric Patients Undergoing HSCT
Completed · Phase 4
Conditions studied: Vitamin D Deficiency, Stem Cell Transplant Complications, Pediatric Cancer, Blood Disorder, Pediatric Acute Myeloid Leukemia, Pediatric Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Sickle Cell Anemia in Children, Aplastic Anemia, Thalassemia in Children
In brief
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.
Key facts
- Study ID
- NCT03176849
- Run by
- Phoenix Children's Hospital
- People needed
- 49
- Starts
- 2017-11-01
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2020-11-17
Who can join
Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Prior rejection of hematopoietic stem cell transplant
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.