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NCT02613884 · ClinicalTrials.gov registry record · Phase 2
Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis
A Phase 2 study, sponsored by Johns Hopkins All Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT02613884 is a Phase 2 study that has completed, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 26 participants.
The verdict
NCT02613884, a Phase 2 study, has completed, sponsored by Johns Hopkins All Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to participate in this study. Upon consent, they will be given oral cholecalciferol supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed by measuring a serum calcium level within 1 week of supplementation. Efficacy will be assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be assessed with the previous two measures as well as a brief questionnaire administered via telephone within 1 week of supplementation.
Interventions
- DRUG Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-11-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02613884
The ClinicalTrials.gov registry entry for NCT02613884 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins All Children's Hospital, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Treatment is the first listed.
NCT02613884 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02613884 about?
NCT02613884 is a clinical study titled "Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis". Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to participate in this study. Upon consent, they will be given oral cholecalciferol supplementation of 250,000 IU during their...
What is the current status of trial NCT02613884?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2016-11. Estimated completion is 2019-11-25.
What interventions are being tested in trial NCT02613884?
The interventions under investigation include: Treatment (DRUG).
Who is sponsoring clinical trial NCT02613884?
This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.
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