Blood PressureNCT02712333
Health Effects of Indoor Air Filtration in Healthy Chinese Adults
A study testing Air Purifiers in people with Blood Pressure, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Air Purifiers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Current or ever smokers
- History of asthma, chronic bronchitis，cough, hypertension or other chronic inflammatory disease
- acute infections
- medication use in recent one month
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Health Effects of Indoor Air Filtration in Healthy Chinese Adults: An Intervention Study
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.
Read the 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
- Being tested
- Air Purifiers, Sham Air Purifiers
- Keywords
- PM2.5, air purification, randomized controlled trial, metabolomics, Metabolites, exhaled nitric oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air PurifiersBehavioural
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 PurifiersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Air purifiers | Experimental | Participants in this group received an intervention of true air purifiers placed in the center of the room. Receives: 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. Receives: Behavioral: Sham Air Purifiers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at the end of each 9-day intervention
Secondary outcomes (3)
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).
Measured: at the end of each 9-day intervention period
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).
Measured: 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).
Measured: at the end of each 9-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidong Kan, Fudan University
- Investigators
- Haidong Kan, Ph.D., Study director, School of Public Health，Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712333
- Sponsor's protocol ID
- FDEH-AF2015
- Status last verified
- May 2017
- First submitted
- 1 Feb 2016
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28808144
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Indoor Air Filtration in Healthy Chinese Adults: An Intervention Study
- ClinicalTrials.gov ID
- NCT02712333
- Acronym / sponsor ID
- FDEH-AF2015
- Conditions
- Blood Pressure
- Keywords
- PM2.5, air purification, randomized controlled trial, metabolomics, Metabolites, exhaled nitric oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 2 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air purifiers | Experimental | Behavioral: Air PurifiersParticipants in this group received an intervention of true air purifiers placed in the center of the room. |
| Control | Sham comparator | Behavioral: Sham Air PurifiersParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Current or ever smokers
- History of asthma, chronic bronchitis，cough, hypertension or other chronic inflammatory disease
- acute infections
- medication use in recent one month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air PurifiersThe 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. | Behavioural | Air purifiers |
| Sham Air PurifiersThe 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. | Behavioural | Control |
Primary outcome
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)
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)
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)
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)
3 secondary outcomes
Systolic Blood Pressure
Time frame: at the end of each 9-day intervention period
Diastolic Blood Pressure
Time frame: at the end of each 9-day intervention
Pulse Pressure
Time frame: at the end of each 9-day intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28808144Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haidong Kan, Ph.D. study director
School of Public Health，Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Purifiers in people with Blood Pressure, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Serum Cortisol Levels (time frame: at the end of each 9-day intervention period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.