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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 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 58 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04170348
The ClinicalTrials.gov registry entry for NCT04170348 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo oral tablet is the first listed.
NCT04170348 reports 0 study locations.
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.
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