Association between exposure to Trihalomethanes (THMs) in chlorinated and ozone/chlorinated swimming pools and metabolome-wide in swimmers
Design
This study is a randomized, single blinded, parallel design clinical trial, with two intervention groups (Swimmers in chlorinated and Ozone/chlorinated swimming pools).
Settings and conduct
This study is at the filed of environmental risk factors and it will be conducted at swimming pools of Tehran city.
After obtaining an informed written consent, volunteers are randomly divided into two groups of 29 (58 totally), in which the level of exposure of individuals with Trihalomethanes (THMs) in two types of swimming pools (1) chlorinated ( intervention group) and (2) Ozone/chlorinated (control group) (In parallel) as well as the metabolome wide of individuals before and after swimming will be measured. Participants are asked to swim in the pool for 40 minutes.
In this study, in order to assess the exposure of participants in each swimming pool, the THMs in indoor air of swimming pools and the THMs in the alveolar air of participants before and after swimming are measured. Also, the main outcome of this study, metabolome levels and changes, will be investigated through their blood samples. All investigators of study outcomes (blood and alveolar air), will be unaware of the allocations.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Young subjects(18- 40 year) and Healthy.
Exclusion criteria: Smokers, Alcoholic, and professional swimmers.
Intervention groups
intervention group1: Participants in the first group will be asked once to swim in chlorinated swimming pool for 40 minutes.
intervention group 2: Participants in the second group will be asked once to to swim in ozone/chlorinated swimming pool for 40 minutes.
Main outcome variables
Levels of metabolome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190515043594N1
Registration date:2019-10-28, 1398/08/06
Registration timing:registered_while_recruiting
Last update:2019-10-28, 1398/08/06
Update count:0
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Ahmad jonidi jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4745
Email address
jonidi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2021-03-06, 1399/12/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Association between exposure to Trihalomethanes (THMs) in chlorinated and ozone/chlorinated swimming pools and metabolome-wide
Public title
Investigation the health effects of exposure to Trihalomethanes (THMs) in swimming pools
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Young adults (18-40 years)
Healthy
Exclusion criteria:
Smoker
Alcoholic
Professional swimmers
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
In order to random allocation of individuals in two groups, the permuted block randomization by using the web based software (www.sealedenvelope.com) will be applied. It should be noted that the length of blocks will be 4.
Blinding (investigator's opinion)
Single blinded
Blinding description
All investigators of study outcomes (blood and alveolar air), will be unaware of the allocations. Also, when the statistical model of the primary and secondary results is not complete, the randomization code will not be broken.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Besides Milad Tower, Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.IUMS.REC.1398.320
Health conditions studied
1
Description of health condition studied
The effects of chlorination and ozonation swimming pools (exposure to THMs) on metabolome profile levels
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Metabolome profile levels. The metabolome represents the complete set of molecule/metabolites in a biological cell, tissue, organ or organism, which are the end products of cellular processes.
Timepoint
At this study, the biological samples (blood) of swimmers before and 15 minuets after swimming will be collected.
Method of measurement
High- Nuclear Magnetic Resonance spectroscopy (H-NMR).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Participants in the first group will be asked once to swim in chlorinated swimming pool for 40 minutes.
Category
Lifestyle
2
Description
Intervention group 2: Participants in the second group will be asked once to swim in Ozone/ chlorinated swimming pool for 40 minutes.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hejab Swimming Pool
Full name of responsible person
Ali Heidari
Street address
Hijab Street, Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1417993361
Phone
+98 21 8898 0562
Email
hejabswimcent@gmail.com
2
Recruitment center
Name of recruitment center
Koosar Swimming Pool
Full name of responsible person
Mansour Faridi
Street address
Jang Street, Bastan Avenue, Jomhori Street, Tehran
City
Tehran
Province
Tehran
Postal code
1417993546
Phone
+98 21 6691 4299
Email
m.faridi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyad Abbas Motavalian
Street address
Iran University of Medical Sciences, Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4704
Fax
+98 21 8862 2707
Email
amotevalian@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
45
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Dr. Iman Eftekhari
Street address
No. 33, 5th Alley, North Karegar Avenue.
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8216 1000
Email
environment@insf.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
Proportion provided by this source
55
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ahmad Jonidi Jafari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Environmental Health
Street address
Iran University of Medical Sciences,Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 86704626
Email
jonidi.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ahmad Jonidi Jafari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Environmental Health
Street address
Iran University of Medical Sciences,Hemmat Highway
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4626
Email
jonidi.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Momeniha
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Environmental Health
Street address
Iran University of Medical Sciences, Besides Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 86701
Email
fa.momeniha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available