Clinical trial NCT02712333: Health Effects of Indoor Air Filtration in Healthy Chinese Adults
Official title: Health Effects of Indoor Air Filtration in Healthy Chinese Adults: An Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: PM2.5
air purification
randomized controlled trial
metabolomics
Metabolites
exhaled nitric oxide
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to detect serum metabolite changes, as well as other health indicators with the intervention of air purifiers on a randomized, crossover, double-blind trial.

Detailed description: The investigators conducted a randomized double-blind crossover trial among 60 healthy college students in Shanghai, China from November to December, 2015. These students lived in dormitories that were randomized into two groups and alternated the use of true or sham air purifiers for 9 consecutive days with a 2-week wash-out interval. All participants and research staffs were blinded to the group assignment. All participants were required to stay in their dormitory with the windows/doors closed for at least 50% of the time on weekdays and for 80% on weekends throughout the 9-day intervention period. All interventions started at 7 a.m. to avoid issues related to diurnal variation. Health endpoints, including blood pressure, fractional exhaled nitric oxide were evaluated and biological samples such as morning urine, fast blood and buccal cells were collected at baseline and immediately after the completion of each intervention period.

Eligibility criteria: Inclusion Criteria:

* Healthy university students in Jiangwan Campus, Fudan university
* Non-smoking, no history of alcohol or drug abuse
* Free of chronic cardiovascular, respiratory, liver and kidney disease
* Spend at least 50% (weekdays) or 80% (weekends) of time indoors

Exclusion Criteria:

* Current or ever smokers
* History of asthma, chronic bronchitis，cough, hypertension or other chronic inflammatory disease
* acute infections
* medication use in recent one month

Primary outcomes:
measure: Changes of Serum Cortisol Levels
timeFrame: at the end of each 9-day intervention period
measure: Changes of Serum Cortisone Concentration
timeFrame: at the end of each 9-day intervention period
measure: Changes of Serum Epinephrine Concentrations
timeFrame: at the end of each 9-day intervention
measure: Changes of Serum Norepinephrine Concentration
timeFrame: at the end of each 9-day intervention
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: at the end of each 9-day intervention period
measure: Diastolic Blood Pressure
timeFrame: at the end of each 9-day intervention
measure: Pulse Pressure
timeFrame: at the end of each 9-day intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: School of Public Health，Fudan University
name: Haidong Kan, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Li H, Cai J, Chen R, Zhao Z, Ying Z, Wang L, Chen J, Hao K, Kinney PL, Chen H, Kan H. Particulate Matter Exposure and Stress Hormone Levels: A Randomized, Double-Blind, Crossover Trial of Air Purification. Circulation. 2017 Aug 15;136(7):618-627. doi: 10.1161/CIRCULATIONAHA.116.026796.