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NCT01967628 · ClinicalTrials.gov registry record · Phase 1
Human Lung Responses to Respiratory Pathogens
A Phase 1 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT01967628: Completed Phase 1 study, sponsored by University of Iowa.
NCT01967628 is a Phase 1 study that has completed, run by University of Iowa. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01967628, a Phase 1 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
For most individuals, the lung has a remarkable ability to deal with exposure to a variety of inhaled bacteria. Some individuals, however, do have recurrent bacterial infections, usually in the form of acute or chronic bronchitis and, in some instances, pneumonia. The reasons for this variability in bacterial infections between otherwise healthy subjects, between types of lung disease, and within the same type of lung disease are poorly understood. Variability in susceptibility to bacterial infections is partially explained by differences in exposure to infectious agents, genetic susceptibility and innate (or early) immune responses. It is of interest that the incidence and severity of bacterial infections is greatest during the winter months. Other than viral infections, there are few variables that change with season. Vitamin D is one known immune modulator with a seasonal periodicity. The hypothesis of this study is that levels of vitamin D are an important determinant of the innate defense of the lung against inhaled bacteria. The investigators further postulate that vitamin D has effects on the innate immune function of both alveolar macrophages and lung epithelial cells.
Primary Outcome
We investigated the effect of vitamin D3 supplementation on airway surface liquid antimicrobial activity using a bioluminescent bacterial challenge. We challenged airway surface liquid samples with bioluminescent bacteria and measured live bacteria by relative light units (RLU) after 2 minutes as a surrogate of antimicrobial activity. We interpreted a reduction in live bacteria after challenge in relative light units as increased antimicrobial activity
Interventions
- DIETARY_SUPPLEMENT Vitamin D3 (cholecalciferol)
- DIETARY_SUPPLEMENT Placebo Sugar Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2007-06 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT01967628 record still lists
NCT01967628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which Vitamin D3 (cholecalciferol) is the first listed.
NCT01967628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01967628 about?
NCT01967628 is a clinical study titled "Human Lung Responses to Respiratory Pathogens". For most individuals, the lung has a remarkable ability to deal with exposure to a variety of inhaled bacteria. Some individuals, however, do have recurrent bacterial infections, usually in the form of acute or chronic bronchitis and, in some instances, pneumonia. The reasons for this variability in...
What is the current status of trial NCT01967628?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2007-06. Estimated completion is 2010-10.
What interventions are being tested in trial NCT01967628?
The interventions under investigation include: Vitamin D3 (cholecalciferol) (DIETARY_SUPPLEMENT), Placebo Sugar Pill (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01967628?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01967628's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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