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NCT01443728 · ClinicalTrials.gov registry record · Phase 2
Vitamin D for Sickle-cell Respiratory Complications
A Phase 2 study of Asthma and Sickle Cell Disease, sponsored by Gary M Brittenham, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01443728: Completed Phase 2 study of Asthma and Sickle Cell Disease, sponsored by Gary M Brittenham, MD.
NCT01443728 is a Phase 2 study of Asthma and Sickle Cell Disease that has completed, run by Gary M Brittenham, MD. The registered enrollment target is 70 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01443728, a Phase 2 study of Asthma and Sickle Cell Disease, has completed, sponsored by Gary M Brittenham, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to answer the question whether oral vitamin D supplementation can decrease lung complications in children and adolescents with sickle cell disease. Lung complications are the leading causes of morbidity and of death in sickle cell disease. Infections and increased inflammation play important roles in the development of the lung problems in sickle cell disease. Emerging evidence shows that vitamin D helps the immune system to fight infection and to control inflammation and could potentially help prevent respiratory complications in patients with sickle cell disease. The investigators hypothesize that oral vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents with sickle cell disease, will reduce the rate of respiratory events (infection, asthma exacerbation and acute chest syndrome) compared to the rate in a group given standard dose oral vitamin D3, 12,000 IU (0.3 mg) given once a month. Funding Source - U.S. Food \& Drug Administration, Office of Orphan Products Development
Primary Outcome
Defined as respiratory infection, acute asthma exacerbation, and acute chest syndrome.
Conditions Studied
Interventions
- DRUG Experimental: Vitamin D3 100,000 IU
- DRUG Active Comparator: Vitamin D3 12,000 IU
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-12-13 |
| Est. Completion | 2015-02-15 |
| Phase | Phase 2 |
What the finished NCT01443728 record still lists
NCT01443728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Experimental: Vitamin D3 100,000 IU is the first listed.
NCT01443728 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01443728 about?
NCT01443728 is a clinical study titled "Vitamin D for Sickle-cell Respiratory Complications". This study aims to answer the question whether oral vitamin D supplementation can decrease lung complications in children and adolescents with sickle cell disease. Lung complications are the leading causes of morbidity and of death in sickle cell disease. Infections and increased inflammation play i...
What is the current status of trial NCT01443728?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2011-12-13. Estimated completion is 2015-02-15.
What conditions does trial NCT01443728 study?
This clinical trial studies the following conditions: Asthma, Sickle Cell Disease, Vitamin D Deficiency, Acute Chest Syndrome, Respiratory Infections.
What interventions are being tested in trial NCT01443728?
The interventions under investigation include: Experimental: Vitamin D3 100,000 IU (DRUG), Active Comparator: Vitamin D3 12,000 IU (DRUG).
Who is sponsoring clinical trial NCT01443728?
This trial is sponsored by Gary M Brittenham, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01443728 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01443728's enrollment target sits among peer trials
70 240th of 374 higher than 132 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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.
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