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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03176849 |
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Date of registration:
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26/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 in Pediatric Patients Undergoing HSCT
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Scientific title:
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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 |
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Date of first enrolment:
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November 1, 2017 |
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Target sample size:
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49 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03176849 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Alexander Ngwube, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Phoenix Children's Hospital |
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Name:
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Kayla Burgett |
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Address:
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Telephone:
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Email:
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Affiliation:
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Phoenix Children's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Year
Age maximum:
25 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aplastic Anemia
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Vitamin D Deficiency
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Sickle Cell Anemia in Children
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Thalassemia in Children
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Myelodysplastic Syndromes
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Pediatric Cancer
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Pediatric Acute Myeloid Leukemia
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Stem Cell Transplant Complications
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Blood Disorder
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Pediatric Acute Lymphoid Leukemia
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Intervention(s)
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Dietary Supplement: Vitamin D3
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Dietary Supplement: Standard Vitamin D3 Supplementation
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Primary Outcome(s)
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Efficacy of vitamin D repletion
[Time Frame: 100 days]
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Safety of Stoss Therapy
[Time Frame: 100 days]
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Secondary Outcome(s)
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Graft-versus-host disease
[Time Frame: 100 days]
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Mortality
[Time Frame: 100 days]
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Infection Rates
[Time Frame: 100 days]
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Rejection
[Time Frame: 100 days]
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Relapse
[Time Frame: 100 days]
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Immune Recovery
[Time Frame: 100 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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