The study of the protective effect efficiency of antioxidant CoQ10 supplement on blood levels of total antioxidant capacity, antioxidant enzymes activity and malondialdehyde of workers in ceramic and printing industries
The study aimed to determine the protective effect of antioxidant CoQ10 supplement on blood levels of oxidative stress bio markers induced by occupational exposure to lead and cadmium metals and organic solvents such as toluene and xylene among workers in ceramic and printing industries. Randomized, double-blind, placebo-controlled crossover trial was selected as a study design. Totally, 40 of the printing industry workers and 40 workers tile industry are consented to participate in the study and having no history of chronic disease, randomly divided into 4 groups. The intervention group consisted of 20 workers who receive capsules 60 mg oral COQ10 twice daily for 60 days and the control group consisted of 20 patients who receive placebo in the same amount. The study includes two intervention phases and one washout period phase. The duration of the intervention phases and washout period phase is two months and one month, respectively and the duration of study will last five months. At the end of the study, the reduction level of oxidative stress will be evaluated by comparing the bio markers level before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061228407N1
Registration date:2016-06-25, 1395/04/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-25, 1395/04/05
Registrant information
Name
Maryam Hormozi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3348 8718
Email address
dr.hormozi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2016-12-10, 1395/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the protective effect efficiency of antioxidant CoQ10 supplement on blood levels of total antioxidant capacity, antioxidant enzymes activity and malondialdehyde of workers in ceramic and printing industries
Public title
The effectiveness of CoQ10 antioxidant supplements in the prevention of the harmful effects of occupational exposure to heavy metals and organic solvents
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having at least one year of experience in the production line; giving consent to participate in the study
Exclusion criteria: History of chronic diseases of the thyroid, liver, kidney, diabetes, cardiovascular disease, cancer and high blood pressure; use of antioxidant supplements by person; Having Positive test G6PDH
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Pardis of the University of Medical Sciences, Doctor Hsabi Squre
City
Zahedan
Postal code
009816743175
Approval date
2016-06-05, 1395/03/16
Ethics committee reference number
ir.zaums.rec.1395.85
Health conditions studied
1
Description of health condition studied
Toxic effect of organic solvents
ICD-10 code
T52.2
ICD-10 code description
Homologues of benzene
2
Description of health condition studied
Toxic effect of metals
ICD-10 code
T56.0
ICD-10 code description
Lead and its compounds
3
Description of health condition studied
Toxic effect of metals
ICD-10 code
T56.3
ICD-10 code description
Cadmium and its compounds
Primary outcomes
1
Description
malondialdehyde
Timepoint
Before the intervention, two months after the intervention.
Method of measurement
Measurement of blood plasma levels of malondialdehyde in terms of nmol per ml
2
Description
total antioxidant capacity
Timepoint
total antioxidant capacity
Method of measurement
Measurement of antioxidant capacity in blood plasma in terms of micromoles per liter
3
Description
Superoxide dismutase activity
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Measurment of the level of erythrocyte superoxide dismutase activity in terms of unit per gram of hemoglobin
4
Description
Glutathione peroxidase activity
Timepoint
Before the intervention, two months after the intervention.
Method of measurement
Measurment of the level of erythrocyte glutathione peroxidase activity in terms of unit per gram of hemoglobin
5
Description
Catalase activity
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Measurment of the level of erythrocyte catalase activity in terms of unit per gram of hemoglobin
Secondary outcomes
1
Description
Headache
Timepoint
Before the intervention and at the end of intervention
Method of measurement
According to Commenting person
2
Description
Nausea
Timepoint
Before the intervention and at the end of intervention
Method of measurement
According to Commenting person
Intervention groups
1
Description
The intervention group consists of 20 workers exposed to organic solvents in the printing industry and 20 workers exposed to heavy metals in the tile industry who received capsules 60 mg oral COQ10 twice daily for 60 days.
Category
Placebo
2
Description
The control group consists of 20 workers exposed to organic solvents in the printing industry and 20 workers exposed to heavy metals in the tile industry who received capsules 60 mg oral placebo twice daily for 60 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tile Industry of Niloofar
Full name of responsible person
Maryam Hormozi, Student of ph.D by.research(Occupational Health)
Street address
Industrial Town, Niloofar Ceramics Industry
City
Birjand
2
Recruitment center
Name of recruitment center
Printing Industry of Golru
Full name of responsible person
Maryam Hormozi, Student of ph.D by.research(Occupational Health)
Street address
Next to SAIPA, Persian Gulf Boulevard
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri (Director of Research)
Street address
Doctor Hesabi Squar
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Hormozi
Position
Faculty Member, Student of ph.D by.research(Occupational Health)
Other areas of specialty/work
Street address
Doctor Hesabi Square
City
Zahedan
Postal code
9816743175
Phone
+98 54 3348 8718
Fax
+98 54 3329 5837
Email
hormozym@yahoo.comdr.hormozi@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ramazan Mirzaei
Position
Ph.D of Occupational Health
Other areas of specialty/work
Street address
Doctor Hesabi Square
City
Zahedan
Postal code
Phone
+98 54 3329 5827
Fax
Email
mirzaei@zaums.ac.ir rammir277@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Hormozi
Position
Faculty Member
Other areas of specialty/work
Street address
Doctor Hesabi Square
City
Zahedan
Postal code
9816743175
Phone
+98 54 3348 8718
Fax
+98 543329837
Email
hormozym@yahoo.comdr.hormozi@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)