Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients

Systemic lupus erythematosus (SLE) is a multisystem chronic autoimmune disease with a relapsing and remitting course. Its prevalence is higher in women of childbearing age of non-white ethnicity. It has a broad spectrum of clinical features ranging from mild cutaneous involvement to severe organ damage, such as kidney failure, pulmonary hypertension, and cardiac failure. The exact etiology of the disease is not well understood well. However, inflammation and oxidative stress are among the most important targets for the management of SLE. Elevated circulating IL-6 concentrations have been consistently observed in patients with systemic lupus erythematosus (SLE) relative to healthy controls, underscoring its pathogenic relevance. In systemic lupus erythematosus (SLE), excessive oxidative stress arising from chronic inflammation and immune complex deposition leads to depletion of endogenous antioxidants, including SOD.

Moreover, diminished SOD activity correlates with disease activity indices such as SLEDAI, suggesting its potential utility as a biomarker for oxidative stress-related disease burden.

melatonin has anti-inflammatory and anti-oxidant characteristics that may aid in the management of autoimmune diseases. In different animal models, melatonin has demonstrated to ameliorate lupus nephritis, reduce inflammation, and improve overall disease pathology. However, these studies have their limitations of being performed in vitro.Only one randomized controlled trial (RCT) was conducted on adult SLE patients and showed improvement in oxidative stress markers, namely malondialdehyde and total antioxidant capacity but no effect on disease activity.

The aim of the current study is to evaluate the effect of melatonin administration on circulating levels of inflammatory mediators, oxidative stress, sleep quality, fatigue and quality of life in patients with SLE. To the best of our knowledge, this is the first randomized-controlled trial to evaluate the impact of melatonin on sleep quality and assess fatigue and quality of life in SLE adult patients. Moreover, the impact of melatonin on serum concentrations of Interleukin-6 and superoxide dismutase SOD will be evaluated.

• SLEDAI -2K Score [Срок оценки: at baseline and then after 12 weeks]
• Serum SOD [Срок оценки: at baseline and after 12 weeks]
• Arabic version form of Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL-Arabic Version) [Срок оценки: at baseline -1st Month-2nd Month-3rd Month]
• Arabic version of Fatigue Severity Scale (FSS) [Срок оценки: at baseline -1st Month-2nd Month-3rd Month]
• Arabic Version of the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: at baseline- 1st Month-2nd Month-3rd Month]
• Incidence of Adverse Effects and Medication Adherence & Modifications [Срок оценки: weekly up to 12 weeks]