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Completed

NCT Number: NCT02712333

Health Effects of Indoor Air Filtration in Healthy Chinese Adults

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.

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Key information

Conditions

Blood Pressure

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes of Serum Cortisol Levels

    Time frame: at the end of each 9-day intervention period

    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)

  2. Changes of Serum Cortisone Concentration

    Time frame: at the end of each 9-day intervention period

    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)

  3. Changes of Serum Epinephrine Concentrations

    Time frame: at the end of each 9-day intervention

    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)

  4. Changes of Serum Norepinephrine Concentration

    Time frame: at the end of each 9-day intervention

    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)

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: at the end of each 9-day intervention period

    To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).

  2. Diastolic Blood Pressure

    Time frame: at the end of each 9-day intervention

    To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).

  3. Pulse Pressure

    Time frame: at the end of each 9-day intervention

    To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Health Effects of Indoor Air Filtration in Healthy Chinese Adults: An Intervention Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 18, 2016
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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