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| ID | Type | Description | Link |
|---|---|---|---|
| N01AI30040-11-0-0 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 (cholecalciferol) | Experimental | Vitamin D3 (1000 international units) daily for 3 months. |
|
| Sugar capsule | Placebo Comparator | Placebo comparator made of sugar in a capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (cholecalciferol) | Dietary Supplement |
| ||
| Placebo Sugar Pill |
| Measure | Description | Time Frame |
|---|---|---|
| Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU) | 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 | 3 months |
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Inclusion Criteria:
Signed informed consent form Age 18 - 60 Healthy nonsmoker, healthy smoker Forced expiratory volume in 1 second (for smokers) > 60% predicted.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia K Gerke, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28883932 | Derived | Vargas Buonfiglio LG, Cano M, Pezzulo AA, Vanegas Calderon OG, Zabner J, Gerke AK, Comellas AP. Effect of vitamin D3 on the antimicrobial activity of human airway surface liquid: preliminary results of a randomised placebo-controlled double-blind trial. BMJ Open Respir Res. 2017 Jun 4;4(1):e000211. doi: 10.1136/bmjresp-2017-000211. eCollection 2017. | |
| 24669961 | Derived | Gerke AK, Pezzulo AA, Tang F, Cavanaugh JE, Bair TB, Phillips E, Powers LS, Monick MM. Effects of vitamin D supplementation on alveolar macrophage gene expression: preliminary results of a randomized, controlled trial. Multidiscip Respir Med. 2014 Mar 26;9(1):18. doi: 10.1186/2049-6958-9-18. |
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Subjects were included if they were 18-60 years.Subjects were excluded if taking a multivitamin or vitamin D supplement within the previous three months, pregnant or breastfeeding,had a vaccination within one month, significant comorbid conditions, respiratory infection, history of positive tuberculin skin test, or use of antibiotics recently.
Subjects were included if they were 18-60 years old and able to understand and sign a consent form. All study procedures were performed at the University of Iowa Hospitals and Clinics bronchoscopy lab and clinical research unit between May 2008 and July 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 | Vitamin D3 (1000 IUs) daily for 3 months. Vitamin D3 (cholecalciferol) |
| FG001 | Sugar Capsule | Placebo comparator made of sugar in a capsule Placebo Sugar Pill |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D ASL | Analysis of airway surface liquid in those taking Vitamin D |
| BG001 | Placebo ASL | Analysis of airway surface liquid in those taking placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU) | 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 | Posted | Mean | 95% Confidence Interval | Relative Light Units (RLU) | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D Airway Surface Liquid | Analysis of airway surface liquid in those taking Vitamin D |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alicia Gerke | University of Iowa | 319-356-1869 | alicia-gerke@uiowa.edu |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Dietary Supplement |
|
| Lost to Follow-up |
|
| Low protein concentration in sample |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Smokers | Count of Participants | Participants |
|
Placebo comparator made of sugar in a capsule Placebo Sugar Pill |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Placebo Airway Surface Liquid | Analysis of airway surface liquid in those taking placebo. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |