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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: Completed Phase 2 study, sponsored by Johns Hopkins All Children's Hospital.
NCT02613884 is a Phase 2 study that has completed, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The safety of a single high-dose of oral cholecalciferol will be assessed using a serum calcium measurement after administration of treatment. Instances of hypercalcemia will be assessed at 1 week and at 3 months post-treatment. The treatment will be considered to be safe if the serum calcium level does not exceed 14 mg/dL.
Interventions
- DRUG Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-11-25 |
| Phase | Phase 2 |
What the finished NCT02613884 record still lists
NCT02613884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment is the first listed.
NCT02613884 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02613884's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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