October 22, 2025Open Access

Effects of melatonin on advanced glycation end products, inflammation, and oxidative stress in peritoneal dialysis patients: a randomized controlled trial

Key Result

Nightly melatonin (5 mg) significantly reduced serum MDA (P=0.03) and hs-CRP (P=0.04) compared to placebo, as well as sICAM-1 and pentosidine, in peritoneal dialysis patients.

Structured PICO

Does melatonin reduce advanced glycation end products, inflammation, and oxidative stress in peritoneal dialysis patients?

Population

44 patients (25 males and 19 females) with chronic kidney failure undergoing continuous ambulatory peritoneal dialysis (CAPD) for at least six months, aged 19 to 75 years, from four peritoneal dialysis centers in Iran. Excluded: inflammatory or infectious diseases, autoimmune disorders, liver diseases, or those receiving NSAIDs, glucocorticoids, estrogen, sedatives, melatonin supplements, or alcohol.

Intervention

Melatonin 5 mg tablet oral one hour before bedtime for 10 weeks

Comparator

Corresponding placebo tablet containing starch each night for 10 weeks

Outcome

Serum high-sensitivity C-reactive protein (hs-CRP), soluble intercellular adhesion molecule type 1 (sICAM-1), malondialdehyde (MDA), pentosidine, carboxymethyl lysine (CML), and glucose at 10 weekssurrogate

Nightly administration of 5 mg melatonin for 10 weeks significantly reduces serum markers of oxidative stress and systemic inflammation in peritoneal dialysis patients.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Advanced glycation end products, systemic and vascular inflammation, and oxidative stress are risk factors for cardiovascular disease in peritoneal dialysis (PD) patients. No studies have examined the effects of melatonin on these risk factors in PD patients. This study was a randomized clinical trial. Forty-four PD patients were randomly assigned to either the melatonin or the placebo group. Participants in the melatonin group received 5 mg melatonin for 10 weeks, while the placebo group received a corresponding placebo. In this study, serum pentosidine, carboxymethyl lysine (CML), high-sensitivity C-reactive protein (hs-CRP), soluble intercellular adhesion molecule type 1 (sICAM-1), malondialdehyde (MDA), and glucose were measured. Serum MDA showed a significant reduction in the melatonin group (P = 0.001), and the reduction was significant compared to the placebo group (P = 0.03). Serum hs-CRP decreased in the melatonin group, and this reduction was significant compared to the placebo group (P = 0.04). Significant reductions were observed in serum sICAM-1 (P = 0.02) and pentosidine (P = 0.03) in the melatonin group. Serum CML and glucose did not show significant changes within each group. This study indicates that nightly administration of 5 mg melatonin reduces MDA, hs-CRP, sICAM-1 and pentosidine, which are cardiovascular risk factors in PD patients. ClinicalTrials.gov: NCT06096558 (23/10/2023).

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