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IRCT2017061234497N1 IRCT 2017-06-20 Kashan University of Medical Sciences Effect of omega-3 plus vitamin E supplementation in treatment of patients with Parkinson's Clinical trial of the effect of omega-3 plus vitamin E supplementation compared with the placebo on levels of gene expression related with glycemic control, lipid and inflammatory factors in patients with Parkinson's 2017-04-20 anticipated 40 Complete https://irct.ir/trial/26350 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline, after balance randomization, subjects will be randomly divided into two groups to take either vitamin E plus omega-3 supplements (n = 20) or placebo (n = 20). Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, 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 Parkinson disease. Intervention 1: Control group: Placebo, daily, for 12 weeks orally. Intervention 2: Intervention group: Omega-3 fatty acid plus vitamin E capsule, 1000 mg omega-3 fatty acid plus 400 IU vitamin E, 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) 8715981151 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with Parkinson's; aged 50 to 80 years. 50 years 80 years Both Subjects who were already taking omega-3 and/or vitamin E Subjects who were taking DDP4 inhibitors, statins and anti-inflammatory drugs Subjects who had depression and had severe psychosis. G20 Parkinson disease Treatment - Drugs Treatment - Drugs Control group: Placebo, daily, for 12 weeks orally. Intervention group: Omega-3 fatty acid plus vitamin E capsule, 1000 mg omega-3 fatty acid plus 400 IU vitamin E, daily for 12 weeks orally. Tumor necrosis factor alpha. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Interleukin-1. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Interleukin-8. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Peroxisome proliferator–activated receptor γ (PPARγ). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Low Density Lipoprotein Receptor (LDLR). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Kashan University of Medical Sciences Approved 2017-04-19 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)