Health Effects of Indoor Air Filtration in Healthy Chinese Adults

NCT ID: NCT02712333

Last Updated: 2017-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-06-30

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Air purifiers

Participants in this group received an intervention of true air purifiers placed in the center of the room.

Group Type: EXPERIMENTAL

Air Purifiers

Intervention Type: BEHAVIORAL

The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment.

Control

Participants in this group received an intervention of sham air purifiers, which were under the same conditions as the true purifiers except the filter gauze in them were removed.

Group Type: SHAM_COMPARATOR

Sham Air Purifiers

Intervention Type: BEHAVIORAL

The control group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms with the windows/doors closed. All participants and research staffs were blinded to the group assignment.

Interventions

Air Purifiers

The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment.

Intervention Type: BEHAVIORAL

Sham Air Purifiers

The control group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms with the windows/doors closed. All participants and research staffs were blinded to the group assignment.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Haidong Kan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haidong Kan, Ph.D.

Role: STUDY_DIRECTOR

School of Public Health，Fudan University

Locations

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 28808144 (View on PubMed)

Other Identifiers

FDEH-AF2015

Identifier Type: -

Identifier Source: org_study_id