Human Lung Responses to Respiratory Pathogens
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form Age 18 - 60 Healthy nonsmoker, healthy smoker Forced expiratory volume in 1 second (for smokers) > 60% predicted.
排除标准
- •Pregnant or breastfeeding
- •Medications (with the exception of hormonal birth control, thyroid medication or prespecified over the counter medications), including multi-vitamins and any preparation that contains vitamin D
- •Heart disease
- •Previous positive tuberculin skin test, or previous diagnosis of tuberculosis
- •Recent respiratory tract infection
- •History of multiple bouts of pneumonia
- •Allergies to caines, atropine, or a history of adverse reaction to narcotics
- •Other factors that increase the risk of bronchoscopy
- •Evidence of acute bronchitis within the past 2 weeks
研究组 & 干预措施
Vitamin D3 (cholecalciferol)
Vitamin D3 (1000 international units) daily for 3 months.
干预措施: Vitamin D3 (cholecalciferol) (Dietary Supplement)
Sugar capsule
Placebo comparator made of sugar in a capsule
干预措施: Placebo Sugar Pill (Dietary Supplement)
结局指标
主要结局
Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU)
时间窗: 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
次要结局
未报告次要终点
研究者
Alicia Gerke
Assistant Professor
University of Iowa
