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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air purifiers | Experimental | Participants in this group received an intervention of true air purifiers placed in the center of the room. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | 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). | at the end of each 9-day intervention period |
| Diastolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haidong Kan, Ph.D. | School of Public Health，Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Environmental Health, School of Public Health, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28808144 | Derived | 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. |
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Recruitment was conducted on November, 2015 in Jiangwan Campus, Fudan University. A total of 65 participants were assessed for eligibility and 60 of them were finally recruited
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1-air Purification First, Then Sham Air Purification | Participants in this group received an intervention of true air purifiers placed in the center of the room. Real Air Purification: 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 as much as possible with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment. |
| FG001 | Group2-sham Air Purification First, Then Real Air Purification | 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. Sham Air Purification: This 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 as much as possible with the windows/doors closed. All participants and research staffs were blinded to the group assignment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period |
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| Second Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group1-air Purification First, Then Sham Air Purification | Participants in this group received a treatment of true air purification first, and then switched to the sham purification treatment the second stage. For real air purification, we used high efficient air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. For sham air purification, we placed a sham air purifier (with HEPA filters removed) while keeping the rest of the experiment conditions and requirements for the participants unchanged. All participants and research staffs were blinded to the group assignment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | relative intensity | at the end of each 9-day intervention period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real Air Purification | Participants in this group received an intervention of true air purifiers placed in the center of the room. Real Air Purification: 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 as much as possible with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Haidong Kan | Fudan University | 86-21-54237908 | kanh@fudan.edu.cn |
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| ID | Term |
|---|---|
| D061808 | Air Filters |
| ID | Term |
|---|---|
| D005374 | Filtration |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D004864 | Equipment and Supplies |
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|
| 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. |
|
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). |
| at the end of each 9-day intervention |
| Pulse Pressure | 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). | at the end of each 9-day intervention |
| NOT COMPLETED |
|
| BG001 | Group2-sham Air Purification First, Then Real Air Purification | Participants in this group received a treatment of sham air purification first, and then switched to the real purification treatment the second stage. For real air purification, we used high efficient air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. For sham air purification, we placed a sham air purifier (with HEPA filters removed) while keeping the rest of the experiment conditions and requirements for the participants unchanged. All participants and research staffs were blinded to the group assignment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| Primary | 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) | Posted | Mean | Standard Error | relative intensity | at the end of each 9-day intervention period |
|
|
|
|
| Primary | 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) | Posted | Mean | Standard Error | relative intensity | at the end of each 9-day intervention |
|
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | relative intensity | at the end of each 9-day intervention |
|
|
|
|
| Secondary | Systolic Blood Pressure | 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). | Posted | Mean | Standard Deviation | mmHg | at the end of each 9-day intervention period |
|
|
|
|
| Secondary | Diastolic Blood Pressure | 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). | Posted | Mean | Standard Deviation | mmHg | at the end of each 9-day intervention |
|
|
|
|
| Secondary | Pulse Pressure | 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). | Posted | Mean | Standard Deviation | mmHg | at the end of each 9-day intervention |
|
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Sham Air Purification | 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. Sham Air Purification: This 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 as much as possible with the windows/doors closed. All participants and research staffs were blinded to the group assignment. | 0 | 55 | 0 | 55 |
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| t-test, 2 sided |
| <0.01 |
| fold change |
| 1.18 |
| 2-Sided |
fold change is calculated by measurments from the sham purification group/measurements from the real purification group |
| Superiority or Other |
| t-test, 2 sided |
| <0.01 |
| fold change |
| 1.20 |
| 2-Sided |
fold change is calculated by measurments from the sham purification group/measurements from the real purification group |
| Superiority or Other |
| t-test, 2 sided |
| <0.01 |
| fold change |
| 1.57 |
| 2-Sided |
fold change is calculated by measurments from the sham purification group/measurements from the real purification group |
| Superiority or Other |