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IRCT20180201038585N1 IRCT 2018-03-10 Bagheiat-allah University of Medical Sciences The effect of supplementation of omega-3 and zinc on the treatment of type 2 diabetes The effect of supplementation of omega-3 and zinc on liver and kidney parameters in type 2 diabetic patients 2016-09-30 anticipated 80 Complete https://irct.ir/trial/29479 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Patients were divided into 4 groups A, B, C, and D by using simple randomization method. . The study groups included omega-3 (A), zinc (B), omega-3 and zinc (C), and placebo-control group (D), Blinding description: Intervention and randomization through a random allocation list was made by a member of the research team as the only non-blind person to be assigned. Other team members (including team leader and study coordinator), as well as all participants, were randomly allocated to blind groups and remained blind until the end of the study. 3 Type 2 diabetes. Intervention 1: Intervention group: Group A = Intervention with omega-3 at a dose of 1000 mg daily one number capsule for 8 weeks - Dana Pharmaceutical Company. Intervention 2: Intervention group: Group B: Intervention with zinc at a dose of 30 mg daily One number tablet for 8 weeks - Dine Pharmaceutical Company. Intervention 3: Intervention group: Group C: Intervention with omega-3 at a dose of 1000 mg plus zinc at a dose of 30 mg daily for 8 weeks. Intervention 4: Control group: Group D:In this study, individuals in the control group received one capsule of starch placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet
public Karim Parastouei
Mollasadra street, Vanak Square, Baqiyatallah University of Medical Sciences
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 parastouei@gmail.com Bagheiat-allah University of Medical Sciences scientific Karim Parastouei
Mollasadra street, Vanak Square, Baqiyatallah University of Medical Sciences
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 parastouei@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Adults with Type 2 Diabetes 18 years 65 years Both Insulin injection Pregnancy and lactation Pancreatic cancer E11 Diabetes mellitus Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: Group A = Intervention with omega-3 at a dose of 1000 mg daily one number capsule for 8 weeks - Dana Pharmaceutical Company Intervention group: Group B: Intervention with zinc at a dose of 30 mg daily One number tablet for 8 weeks - Dine Pharmaceutical Company Intervention group: Group C: Intervention with omega-3 at a dose of 1000 mg plus zinc at a dose of 30 mg daily for 8 weeks Control group: Group D:In this study, individuals in the control group received one capsule of starch placebo Alanine aminotransferase. Timepoint: At weeks 0, 8. Method of measurement: Enzymatic method-IU/Lit. Aspartate aminotransferase. Timepoint: At weeks 0, 8. Method of measurement: Enzymatic method-IU/Lit. Gamma glutamyl transpeptidase. Timepoint: At weeks 0, 8. Method of measurement: Enzymatic method-IU/Lit. Alkaline phosphatase. Timepoint: At weeks 0, 8. Method of measurement: Enzymatic method-IU/Lit. Creatinine. Timepoint: At weeks 0, 8. Method of measurement: Enzymatic method, mg/dl. Uric acid. Timepoint: At weeks 0, 8. Method of measurement: Enzymatic method, mg/dl. Urea. Timepoint: At weeks 0, 8. Method of measurement: Enzymatic method, mg/dl. Baqiyatallah University of Medical Sciences Approved 2017-05-02 The Ethics Committee of the University of Medical Sciences Mollasadra street, Vanak Square, Baqiyatallah University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)