Health Effects of Indoor Air Filtration in Healthy Chinese Adults

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712333
• Other study ID #: FDEH-AF2015
• Status: Completed
• Phase: N/A
• First received: February 1, 2016
• Last updated: May 5, 2017
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Behavioral:
• Air Purifiers
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
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.

Locations

Country	Name	City	State
China	Department of Environmental Health, School of Public Health, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	at the end of each 9-day intervention period
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)	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)	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)	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).	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).	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).	at the end of each 9-day intervention