Trial Outcomes & Findings for Health Effects of Indoor Air Filtration in Healthy Chinese Adults (NCT NCT02712333)
NCT ID: NCT02712333
Last Updated: 2017-10-02
Results Overview
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)
COMPLETED
NA
60 participants
at the end of each 9-day intervention period
2017-10-02
Participant Flow
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
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Period
STARTED
|
34
|
26
|
|
First Period
COMPLETED
|
31
|
24
|
|
First Period
NOT COMPLETED
|
3
|
2
|
|
Second Period
STARTED
|
31
|
24
|
|
Second Period
COMPLETED
|
31
|
24
|
|
Second Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First Period
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Health Effects of Indoor Air Filtration in Healthy Chinese Adults
Baseline characteristics by cohort
| Measure |
Group1-air Purification First, Then Sham Air Purification
n=31 Participants
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.
|
Group2-sham Air Purification First, Then Real Air Purification
n=24 Participants
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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.0 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
20.6 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
20.2 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Body mass index
|
21.6 kg/m^2
STANDARD_DEVIATION 2.9 • n=5 Participants
|
20.6 kg/m^2
STANDARD_DEVIATION 2.5 • n=7 Participants
|
21.1 kg/m^2
STANDARD_DEVIATION 2.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: at the end of each 9-day intervention periodUsing 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)
Outcome measures
| Measure |
Real Purification
n=55 Participants
Participants in this group received a treatment of air purification.
|
Sham Purification
n=55 Participants
Participants received sham air purification first.
|
|---|---|---|
|
Changes of Serum Cortisol Levels
|
0.012835 relative intensity
Standard Deviation 0.00371
|
0.016206 relative intensity
Standard Deviation 0.00474
|
PRIMARY outcome
Timeframe: at the end of each 9-day intervention periodUse 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)
Outcome measures
| Measure |
Real Purification
n=55 Participants
Participants in this group received a treatment of air purification.
|
Sham Purification
n=55 Participants
Participants received sham air purification first.
|
|---|---|---|
|
Changes of Serum Cortisone Concentration
|
0.021076 relative intensity
Standard Error 0.004375
|
0.024338 relative intensity
Standard Error 0.004625
|
PRIMARY outcome
Timeframe: at the end of each 9-day interventionUse 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)
Outcome measures
| Measure |
Real Purification
n=55 Participants
Participants in this group received a treatment of air purification.
|
Sham Purification
n=55 Participants
Participants received sham air purification first.
|
|---|---|---|
|
Changes of Serum Epinephrine Concentrations
|
0.140609 relative intensity
Standard Error 0.027514
|
0.165321 relative intensity
Standard Error 0.036633
|
PRIMARY outcome
Timeframe: at the end of each 9-day interventionUse 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)
Outcome measures
| Measure |
Real Purification
n=55 Participants
Participants in this group received a treatment of air purification.
|
Sham Purification
n=55 Participants
Participants received sham air purification first.
|
|---|---|---|
|
Changes of Serum Norepinephrine Concentration
|
0.030752 relative intensity
Standard Deviation 0.024335
|
0.038695 relative intensity
Standard Deviation 0.024624
|
SECONDARY outcome
Timeframe: at the end of each 9-day intervention periodTo 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).
Outcome measures
| Measure |
Real Purification
n=55 Participants
Participants in this group received a treatment of air purification.
|
Sham Purification
n=55 Participants
Participants received sham air purification first.
|
|---|---|---|
|
Systolic Blood Pressure
|
102.2 mmHg
Standard Deviation 13.4
|
104.8 mmHg
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: at the end of each 9-day interventionTo 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).
Outcome measures
| Measure |
Real Purification
n=55 Participants
Participants in this group received a treatment of air purification.
|
Sham Purification
n=55 Participants
Participants received sham air purification first.
|
|---|---|---|
|
Diastolic Blood Pressure
|
64.5 mmHg
Standard Deviation 9.6
|
65.2 mmHg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: at the end of each 9-day interventionTo 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).
Outcome measures
| Measure |
Real Purification
n=55 Participants
Participants in this group received a treatment of air purification.
|
Sham Purification
n=55 Participants
Participants received sham air purification first.
|
|---|---|---|
|
Pulse Pressure
|
37.7 mmHg
Standard Deviation 7.5
|
39.6 mmHg
Standard Deviation 8.3
|
Adverse Events
Real Air Purification
Sham Air Purification
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place