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NCT03176849 · ClinicalTrials.gov registry record · Phase 4
A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 in Pediatric Patients Undergoing HSCT
A Phase 4 study of Myelodysplastic Syndromes and Pediatric Cancer, sponsored by Phoenix Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT03176849: Completed Phase 4 study of Myelodysplastic Syndromes and Pediatric Cancer, sponsored by Phoenix Children's Hospital.
NCT03176849 is a Phase 4 study of Myelodysplastic Syndromes and Pediatric Cancer that has completed, run by Phoenix Children's Hospital. The registered enrollment target is 49 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03176849, a Phase 4 study of Myelodysplastic Syndromes and Pediatric Cancer, has completed, sponsored by Phoenix Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
In order to monitor the safety of stoss therapy, patients will be monitored for any clinical signs or symptoms of hypervitaminosis D, including abdominal pain, dehydration, and fatigue. Patients will be monitored for hypercalcemia and hyperphosphatemia with weekly complete metabolic panels and serum phosphorus during the first 100 days of transplant. Patients will have repeat measurements of serum 25(OH)D levels will be obtained at Day +30 to ensure they do not have hypervitaminosis D at that ti
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Vitamin D3
- DIETARY_SUPPLEMENT Standard Vitamin D3 Supplementation
Study Locations (1)
Arizona
- Phoenix Children's Hospital - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2019-07-01 |
| Phase | Phase 4 |
What the finished NCT03176849 record still lists
NCT03176849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (83% lower).
The record links to 10 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Vitamin D3 is the first listed.
NCT03176849 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03176849 about?
NCT03176849 is a clinical study titled "A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 in Pediatric Patients Undergoing HSCT". 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 ...
What is the current status of trial NCT03176849?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2017-11-01. Estimated completion is 2019-07-01.
What conditions does trial NCT03176849 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Pediatric Cancer, Vitamin D Deficiency, Aplastic Anemia, Stem Cell Transplant Complications.
What interventions are being tested in trial NCT03176849?
The interventions under investigation include: Vitamin D3 (DIETARY_SUPPLEMENT), Standard Vitamin D3 Supplementation (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03176849?
This trial is sponsored by Phoenix Children's Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03176849 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03176849's enrollment target sits among peer trials
49 89th of 173 higher than 84 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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