]>
IRCT201502255623N36 IRCT 2015-03-10 Kashan University of Medical Sciences Effects omega-3 fatty acid supplementation in the treatment of diabetes Effects of omega-3 fatty acid supplementation on metabolic profiles, hs-CRP and biomarkers of oxidative stress in diabetic nephropaty patients 2015-03-11 anticipated 60 Complete https://irct.ir/trial/6066 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either omega-3 fatty acid supplement or placebo. Randomization will be done by the use of Stat Trek software. https://stattrek.com/statistics/random-number-generator.aspx, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Akhavan Clinic in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 2 Diabetic nephropathy. Intervention 1: Intervention group: Omega-3 fatty acid pearl, 1000 mg, daily, for 12 weeks orally. Intervention 2: Control group: Placebo pearl, daily, for 12 weeks orally. 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 Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5562 0608 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Bolvare Ghotbe Ravandi, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with diabetic nephropathy aged 45 to 85 years. Proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels 45 years 85 years Both The intake of omega-3 fatty acid supplements within 3 months Patients with uncontrolled diabetes The current use of warfarin Malignancy and/or liver cirrhosis. E10 Insulin-dependent diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group: Omega-3 fatty acid pearl, 1000 mg, daily, for 12 weeks orally. Control group: Placebo pearl, daily, for 12 weeks orally. Insulin resistance. Timepoint: Baseline and End-of-trial. Method of measurement: Calculation using HOMA formula. Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: ELISA kit. High-sensitivity C-reactive protein. Timepoint: Baseline and End-of-trial. Method of measurement: ELISA test. Malondialdehyde. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Glutathione. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Nitric oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Triglycerides. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit. HDL. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit. Fasting blood sugar. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit. LDL. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic kit. Blood Urea Nitrogen. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Serum Creatinine. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Kashan University of Medical Sciences Approved 2015-02-28 Kashan University of Medical Sciences Bolvare Ghotbe Ravandi, Kashan Kashan Isfehan Iran (Islamic Republic of)