跳至主要内容
临床试验/NCT01967628
NCT01967628已完成1 期

Human Lung Responses to Respiratory Pathogens

University of Iowa2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2007年6月最近更新:
适应症
干预措施

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

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)

Experimental

Vitamin D3 (1000 international units) daily for 3 months.

干预措施: Vitamin D3 (cholecalciferol) (Dietary Supplement)

Sugar capsule

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alicia Gerke

Assistant Professor

University of Iowa

研究点 (2)

Loading locations...

相似试验

招募中
不适用
Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary TuberculosisTB - TuberculosisHIV/AIDS
NCT04700579University of Stellenbosch150
招募中
不适用
Lung Innate Immunity and Microbiome After Tuberculosis ExposureLatent TuberculosisTuberculosis
NCT06526689University of Oxford50
招募中
不适用
Susceptibility to respiratory tract infectionsATEMWEGSINFEKTANFLLIGKEITJ00J01J02J03J04J05J06J12J13J14J15J16J17J18J20J21J22Acute nasopharyngitis [common cold]Acute sinusitisAcute laryngitis and tracheitisAcute obstructive laryngitis [croup] and epiglottitisAcute upper respiratory infections of multiple and unspecified sitesViral pneumonia, not elsewhere classifiedPneumonia due to Streptococcus pneumoniaePneumonia due to Haemophilus influenzaeBacterial pneumonia, not elsewhere classifiedPneumonia due to other infectious organisms, not elsewhere classifiedPneumonia in diseases classified elsewherePneumonia, organism unspecifiedUnspecified acute lower respiratory infectionAcute bronchiolitisAcute pharyngitisAcute bronchitisAcute tonsillitis
DRKS00003381niversitätsklinikum Freiburg1,500
已完成
不适用
Evaluation of Lungs of Normal Individuals by Lung Lavage, Brushing and Bronchial Wall BiopsySmokingLung Diseases
NCT00224185Weill Medical College of Cornell University196
已完成
不适用
Use of Exhaled Particles to Assess Lung PharmacokineticsHealthyLung Pharmacokinetic
NCT04914273Fraunhofer-Institute of Toxicology and Experimental Medicine6