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IRCT20200322046834N1 IRCT 2020-04-23 Shiraz University of Medical Sciences Assessment of vitamin C and E effect in prevent of disease in workers Assessment of E & C vitamins effects on oxidative stress biomarkers, biochemical parameters, Depression, anxiety and stress in workers exposed to noise, cement dust and silica in SHIRAZ cement plant. 2020-07-20 anticipated 80 Complete https://irct.ir/trial/46679 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, because the cement plant consisted of different sections, We chose the stratified randomization method, In this study we have seven units in cement plant and With regard to the number of people in each section we chose our community to participate in this study.After stratified randomization and selection of the total sample size (80)select workers we use flip the coin method to choose participants for intervention and the group of vitamins intervention and placebo intervention will be determined, Blinding description: In this study we will provide placebo tablet similar to the original tablets content C and E vitamins.Then vitamins and placebos will give to participants by assistant, researcher and participants will not aware of content of tablets. 3 The participant of this study are workers who exposed to harmful agent include cement dust, silica, noise in cement plant. Intervention 1: Intervention group: This group will 40 participants that use vitamin E and vitamin C, The does of them by arrangement are 400 IU and 500mg. They will use these vitamins for tow month and our assistant give its to them every day after lunch. these vitamins product by Dena Pharmaceutical Company. Intervention 2: Control group: This group will 40 participants that use placepo for tow month and our assistant give its to them every day after lunch. The content of them is sugar. these placebos product by Dena Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: The data about participants such as main variable can be share after unrecognizable our participants When: The time to accesses the information will be four month after publish the results To whom: The information will be available to researchers every where, And we will give the information to people who working in industry. Conditions: After do statistical analyses on our information we publish the data in an article, So it will be available for every one. Where to obtain: Individuals can access the article by searching the subjects name that we express, And the article will include the editors email address to answer questions. How to obtain: After publish the article editor will be online to answer your request, And the process of doing this project and publish article about it has need 8 month nearly Comments:
public Faeze Darabi
school of health, front of the Bargh club, Razi Blvd, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 6719683515 +98 83 3837 2107 faeze.darabi@gmail.com Shiraz University of Medical Sciences scientific Faezeh Darabi
No 45. Hedayat Street, Soratgar Blvd.
Shiraz Iran (Islamic Republic of) 7134953884 +98 71 3235 1268 faeze.darabi@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Have at least 5 years job experience sign the written informed consent 20 years 50 years Male Workers have underlying disease including diabetes, heart disease, kidney disease,gastrointestinal discomfort, and hypertension Using particular drug or vitamins that effect on our intervention Prevention Placebo Intervention group: This group will 40 participants that use vitamin E and vitamin C, The does of them by arrangement are 400 IU and 500mg. They will use these vitamins for tow month and our assistant give its to them every day after lunch. these vitamins product by Dena Pharmaceutical Company. Control group: This group will 40 participants that use placepo for tow month and our assistant give its to them every day after lunch. The content of them is sugar. these placebos product by Dena Pharmaceutical Company. Malondialdehyde. Timepoint: malondialdehyde measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Malondialdehyde will measure based on its reaction with thiobarbituric acid reactive substances and will determine by using fluorimetry. Total antioxidant capacity. Timepoint: Total antioxidant capacity measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Total antioxidant capacity will be measured by ferric reducing ability in plasma method. Superoxide dismutase. Timepoint: Superoxide dismutase measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Activity of superoxide dismutase will measure by superoxide dismutase kit. Catalase. Timepoint: Catalase measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Catalase enzyme will determine by catalase kit. Alkaline phosphatase. Timepoint: Alkaline phosphatasemeasurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Alkaline phosphatase will be measured by using standard kit and auto analyzer system. Alanine transaminase. Timepoint: Alanine transaminasemeasurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: alanine transaminase will be measured by using standard kit and auto analyzer system. Aspartate transaminase. Timepoint: Aspartate transaminasemeasurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Aspartate transaminase will be measured by using standard kit and auto analyzer system. High density lipid. Timepoint: High density lipid measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: High density lipid will be measured by using standard kit and auto analyzer system. Low density lipid. Timepoint: Low density lipid measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Low density lipid will be measured by using standard kit and auto analyzer system. Triglyceride. Timepoint: Triglyceride measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Triglyceride will be measured by using standard kit and auto analyzer system. Total bilirubin. Timepoint: Total bilirubin measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Total bilirubin will be measured by using standard kit and auto analyzer system. Glucose. Timepoint: Glucose measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Glucose will be measured by using standard kit and auto analyzer system. Albumin. Timepoint: Albumin measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Albumin will be measured by using standard kit and auto analyzer system. Creatinine. Timepoint: Creatinine measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: creatinine will be measured by using standard kit and auto analyzer system. Cholesterol. Timepoint: Cholesterol measurement will be performed One day befor the intervention, And one day after the intervention. Method of measurement: Cholesterol will be measured by using standard kit and auto analyzer system. Depression. Timepoint: The DASS-21 questionnaire will be filled by the participants one day befor intervention and one day after intervention. Method of measurement: Participants' depression will be obtained by using the total score obtained from filling out the questions. Stress. Timepoint: The DASS-21 questionnaire will be filled by the participants one day befor intervention and one day after intervention. Method of measurement: Participants' stress will be obtained by using the total score obtained from filling out the questions. Anexiety. Timepoint: The DASS-21 questionnaire will be filled by the participants one day befor intervention and one day after intervention. Method of measurement: Participants' anexity will be obtained by using the total score obtained from filling out the questions. Shiraz University of Medical Sciences Approved 2019-05-07 Shiraz University of Medical Sciences Ethics Committee No. 11, Second Alley, Second 16 meters Street, Shahid Najafi Quarter, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)