Human Lung Responses to Respiratory Pathogens
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|ClinicalTrials.gov Identifier: NCT01967628|
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
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 :||98 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|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||October 2010|
Experimental: Vitamin D3 (cholecalciferol)
Vitamin D3 (1000 international units) 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
- Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU) [ Time Frame: 3 months ]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
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|