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IRCT20210717051914N2 IRCT 2022-12-09 Ahvaz University of Medical Sciences effect of selenium in systemic lupus erythematosus Investigating the effect of selenium supplementation on disease activity, serum levels of some oxidative stress factors, anti-ds DNA antibody (Anti-ds DNA) and high sensitivity C-reactive protein (hs CRP) in patients with systemic lupus erythematosus (LES) . 2022-11-22 anticipated 56 Complete https://irct.ir/trial/66456 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method will be used to assign people to study groups. Based on sextet blocks, people are assigned to two groups of receiving selenium supplement and placebo. In order to randomize the entry of samples into each of the groups, the package containing the supplement and placebo will be labeled as A and B. Before starting the study, the relevant packages are coded by a person other than the researcher as group A containing selenium supplement or placebo and group B containing selenium supplement or placebo, Blinding description: In order to reduce the possibility of information bias, a double-blind method will be used. In this way, both the patients and the researcher and the person evaluating the treatment results will be kept unaware of the type of treatment assigned to the people. Also, in order to reduce the possibility of selection bias, Allocation Concealment method or use of unit codes is used after randomization. In this way, all containers containing supplements and placebo, which are completely similar in appearance, are coded as A and B by someone outside the study, and breaking the code will be possible only by the person who did the numbering. 3 Systemic lupus erythematosus. Intervention 1: Intervention group: 28 people receiving tablets containing 200 micrograms of selenium (selenomethionine form), manufactured by Health Burst, one tablet daily for 8 weeks after meals. Intervention 2: Control group: 28 people receiving placebo tablets containing corn starch, prepared by the growth center of Jundishapur University of Ahvaz, one tablet daily for 8 weeks after meals. 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 There is no further information
public Hengameh Abrishamkar
Golestan Blvd., Jundishapur University of Medical Sciences, Faculty of Paramedicine
Ahwaz Iran (Islamic Republic of) 615715794 +98 61 3311 0000 abrishamkar.h@ajums.ac.ir Ahvaz University of Medical Sciences scientific Bizhan Helli
Golestan Blvd., Jundishapur University of Medical Sciences, Faculty of Paramedicine
Ahwaz Iran (Islamic Republic of) 6135715794 +98 61 3311 0000 Helli-b@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 15 to 60 years Having at least four of the clinical and immunological diagnostic criteria for systemic lupus erythematosus Body mass index equal to and less than 35 15 years 60 years Both Suffering from other autoimmune and rheumatological diseases Pregnancy and breastfeeding Severe liver diseases Severe renal failure Severe and active infections Taking selenium supplements during the last two months Recent excessive consumption of antioxidant supplements (such as vitamin C, vitamin E, omega 3, etc.) or their consumption during the intervention History of allergy to selenium supplements Other cancers Body mass index above 35 M32.9 Systemic lupus erythematosus, unspecified Treatment - Drugs Placebo Intervention group: 28 people receiving tablets containing 200 micrograms of selenium (selenomethionine form), manufactured by Health Burst, one tablet daily for 8 weeks after meals Control group: 28 people receiving placebo tablets containing corn starch, prepared by the growth center of Jundishapur University of Ahvaz, one tablet daily for 8 weeks after meals. Disease activity. Timepoint: At the beginning and after 8 weeks of intervention. Method of measurement: By completing the questionnaire to measure the severity of systemic lupus erythematosus disease activity. Anti-double-stranded DNA antibody. Timepoint: At the beginning and after 8 weeks of intervention. Method of measurement: Using the ELISA kit. High-sensitivity C-reactive protein. Timepoint: At the beginning and after 8 weeks of intervention. Method of measurement: Using the ELISA kit. Glutathione peroxidase. Timepoint: At the beginning and after 8 weeks of intervention. Method of measurement: Using the ELISA kit. Malondialdehyde. Timepoint: At the beginning and after 8 weeks of intervention. Method of measurement: Using the ELISA kit. Total antioxidant capacity. Timepoint: At the beginning and after 8 weeks of intervention. Method of measurement: Using the ELISA kit. Ahvaz University of Medical Sciences Approved 2022-11-15 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)