Health Effects of Indoor Air Filtration in Healthy Chinese Adults

NCT02712333 | Completed Results DMC

• 1 other identifier: FDEH-AF2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

PM2.5; air purification; randomized controlled trial; metabolomics; Metabolites; exhaled nitric oxide

Outcome Measures

Primary Outcomes (4)

• Changes of Serum Cortisol Levels

  Using metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification. Relative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)

  at the end of each 9-day intervention period

• Changes of Serum Cortisone Concentration

  Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification. Relative intensity was calculated by dividing the peak intensity of cortisone with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)

  at the end of each 9-day intervention period

• Changes of Serum Epinephrine Concentrations

  Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification. Relative intensity was calculated by dividing the peak intensity of epinephrine with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)

  at the end of each 9-day intervention

• Changes of Serum Norepinephrine Concentration

  Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification. Relative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)

  at the end of each 9-day intervention

Secondary Outcomes (3)

• Systolic Blood Pressure

  at the end of each 9-day intervention period

• Diastolic Blood Pressure

  at the end of each 9-day intervention

• Pulse Pressure

  at the end of each 9-day intervention

Study Arms (2)

Air purifiers

EXPERIMENTAL

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

Behavioral: Air Purifiers

Control

SHAM COMPARATOR

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.

Behavioral: Sham Air Purifiers

Interventions

Air Purifiers 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.

Air purifiers

Sham Air Purifiers 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.

Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 28808144 DERIVED

MeSH Terms

Interventions

Air Filters

Intervention Hierarchy (Ancestors)

Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Equipment and Supplies

Results Point of Contact

• Title: Dr. Haidong Kan
• Organization: Fudan University

kanh@fudan.edu.cn

86-21-54237908

Study Officials

• Haidong Kan, Ph.D.

  School of Public Health，Fudan University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: March 18, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 2, 2017
• Results First Posted: October 2, 2017

Record last verified: 2017-05

Locations

CN (1)