The effects of melatonin administration on disease severity and sleep quality in children with atopic dermatitis: A randomized, double-blinded, placebo-controlled trial

Background: The aim of this clinical trial was to determine the effects of melatonin administration on disease severity and sleep quality in children diagnosed with atopic dermatitis (AD). Methods: This randomized, double-blinded, placebo-controlled trial was conducted by recruiting 70 patients, aged 6-12 years, who had been diagnosed with AD. Study participants were randomly allocated into two intervention groups to receive either 6 mg/d melatonin supplements or placebo (n = 35 each group) for 6 weeks. Severity of disease was assessed using the scoring atopic dermatitis (SCORAD) and objective SCORAD indices. Sleep quality was evaluated by completing the Children's Sleep Habits Questionnaire (CSHQ). Results: Following 6 weeks of intervention, melatonin supplementation significantly improved SCORAD index (β −3.55; 95% CI, −6.11, −0.98; P = 0.007), objective SCORAD index (β −3.23; 95% CI, −5.08, −1.38; P = 0.001), serum total IgE levels (β −153.94 ku/L; 95% CI, −260.39, −47.49; P = 0.005), and CSHQ scores (β −2.55; 95% CI, −4.34, −0.75; P = 0.006). However, melatonin had no significant impact on pruritus scores, high-sensitivity C-reactive protein (hs-CRP), sleep-onset latency, total sleep time, weight, and BMI compared with placebo. Conclusions: Overall, melatonin supplementation had beneficial effects on disease severity, serum total IgE levels, and CSHQ among children diagnosed with AD.