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) .

Determining the effect of selenium supplementation on disease activity, oxidative stress, anti-ds DNA and hs CRP in patients with systemic lupus erythematosus

A double-blind randomized clinical trial with a control group, with parallel groups, on 56 patients with systemic lupus erythematosus, with with randomization and double-blind method

Referred to Ahvaz rheumatology clinic in 2022, selection of 56 patients based on inclusion and exclusion criteria, randomization into two intervention and control groups, blinding of patients and researcher, coding by someone outside the study.

People are divided into two intervention and control groups. inclusion criteria include: age 15 to 60 years, having at least four clinical and immunological diagnostic criteria for systemic lupus erythematosus, body mass index equal to and less than 35 Non-entry criteria include: suffering from other autoimmune and rheumatological diseases, pregnancy and breastfeeding, severe liver diseases, severe renal failure, severe and active infections, taking selenium supplements in the last two months, recent excessive use of antioxidant supplements (such as vitamin C, vitamin E, omega 3, etc.) or their consumption during intervention, history of allergy to selenium supplements, suffering from other cancers

supplement group : 28 people who received a tablet containing 200 micrograms of selenium daily for 8 weeks. placebo group: 28 people receiving a daily placebo pill containing corn starch for 8 weeks

Disease activity, hs-CRP, serum levels of Anti ds-DNA, oxidative stress factors (malondialdehyde, glutathione peroxidase, total antioxidant capacity)

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.

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.