Human Lung Responses to Respiratory Pathogens
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|ClinicalTrials.gov Identifier: NCT01967628|
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : November 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Infection||Dietary Supplement: Vitamin D3 (cholecalciferol) Dietary Supplement: Placebo Sugar Pill||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Human Lung Responses to Respiratory Pathogens|
|Study Start Date :||June 2007|
|Primary Completion Date :||July 2010|
|Study Completion Date :||October 2010|
Experimental: Vitamin D3
Vitamin D3 (1000 IUs) daily for 3 months.
|Dietary Supplement: Vitamin D3 (cholecalciferol)|
Placebo Comparator: Sugar capsule
Placebo comparator made of sugar in a capsule
|Dietary Supplement: Placebo Sugar Pill|
- Differential gene expression of the alveolar macrophage by microarray analysis [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967628
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Alicia K Gerke, MD||University of Iowa|