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IRCT20190924044869N1 IRCT 2020-06-14 Kashan University of Medical Sciences Effect of Selenium supplementation in rheumatoid arthritis Comparison of the effectiveness of selenium with placebo on disease activity and inflammatory factors and oxidative stress in patients with rheumatoid arthritis 2020-02-20 anticipated 60 Complete https://irct.ir/trial/42513 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 66 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes. Supplements and placebos are in the same packaging at the Pharmaceutical company. Only the code is written on the packages. Patients and researchers do not know the type of intervention and after analyzing the data, packet codes are decoded, Blinding description: Participants, investigators or the assessors of the outcomes are unaware of the study groups. 3 Rheumatoid arthritis. Intervention 1: The intervention group will receive one Selenium tablet 200 microgram tablet daily for 12 weeks. Intervention 2: The control group will receive one placebo tablet daily for 12 weeks. Yes - There is a plan to make this available What will be shared: A portion of the data regarding demographics, anthropometric, and food variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared. When: The start of the data access period will be one year after the publication of the result. To whom: Researchers working in academic institutions Conditions: In order to conduct meta analysis studies Where to obtain: Nasrin Sharifi, Nutrition Department, School of Medicine, Kashan University of Medical Sciences, Qotbe-e-Ravandi Blvd., Kashan, Iran Postal Code: 88715973474 E-mail: sharifi-na@kaums.ac.ir Tel: 00983155540021 Fax: 00983155620608 How to obtain: An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request Comments:
public Fereshte Taghvaee
Qhotbe Ravandi Blvd
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0021 fsh.taghvaee@gmail.com Kashan University of Medical Sciences scientific Nasrin Sharifi
Qhotbe Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5562 0608 sharifi-na@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) patients with active rheumatoid arthritis aged 18 to 75 years. 18 years 75 years Both active infection high and moderate blood pressure (systolic pressure less than 140 and diastolic pressure less than 90 mmHg) smoking concurrent rheumatologic disease Hypothyroidism or hyperthyroidism Kidney or liver failure M05 Rheumatoid arthritis with rheumatoid factor Treatment - Drugs Placebo The intervention group will receive one Selenium tablet 200 microgram tablet daily for 12 weeks. The control group will receive one placebo tablet daily for 12 weeks. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Kashan University of Medical Sciences Approved 2020-02-03 committee of Kashan University of medical sciences Ghotbe Ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)