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NCT04170348 · ClinicalTrials.gov registry record · Phase 2
Daily Vitamin D for Sickle-cell Respiratory Complications
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT04170348: Completed Phase 2 study, sponsored by Columbia University.
NCT04170348 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04170348, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
This study aims to answer the question whether daily oral vitamin D supplementation can reduce the risk of respiratory or lung complications in children and adolescents with sickle cell disease. Respiratory problems are the leading causes of sickness and of death in sickle cell disease. The investigators hypothesize that daily oral vitamin D3, compared to monthly oral vitamin D, will rapidly increase circulating vitamin D3, and reduce the rate of respiratory complications by 50% or more within the first year of supplementation in children and adolescents with sickle cell disease. This study is funded by the FDA Office of Orphan Products Development (OOPD).
Primary Outcome
Respiratory events will be calculated as the sum of respiratory infection, asthma exacerbation, and acute chest syndrome, as ascertained by use of a validated questionnaire.
Interventions
- DRUG Placebo oral tablet
- DRUG Daily oral vitamin D3, 3,333 IU
- DRUG Monthly oral vitamin D3, 100,000 IU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2024-06-18 |
| Phase | Phase 2 |
What the finished NCT04170348 record still lists
NCT04170348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral tablet is the first listed.
NCT04170348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04170348 about?
NCT04170348 is a clinical study titled "Daily Vitamin D for Sickle-cell Respiratory Complications". This study aims to answer the question whether daily oral vitamin D supplementation can reduce the risk of respiratory or lung complications in children and adolescents with sickle cell disease. Respiratory problems are the leading causes of sickness and of death in sickle cell disease. The investig...
What is the current status of trial NCT04170348?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-09-15. Estimated completion is 2024-06-18.
What interventions are being tested in trial NCT04170348?
The interventions under investigation include: Placebo oral tablet (DRUG), Daily oral vitamin D3, 3,333 IU (DRUG), Monthly oral vitamin D3, 100,000 IU (DRUG).
Who is sponsoring clinical trial NCT04170348?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04170348's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 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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