Effects of Oral Melatonin Supplementation on Inflammatory and Oxidative Stress Markers, Metabolic Parameters, Blood Pressure, and Sleep Quality in Patients With Stage 3 - 4 Chronic Kidney Disease: A Randomized, Double-Blind, Placebo-Controlled Trial

AuthorShadi Ziaieen
AuthorFatemeh Pourrezagholieen
AuthorAylar Nadiri Nirien
AuthorBehnam Mahdavien
AuthorMohammad Abbasinazarien
AuthorRoja Asadpouren
OrcidShadi Ziaie [0000-0002-4358-470X]en
OrcidFatemeh Pourrezagholie [0000-0001-7534-8309]en
OrcidRoja Asadpour [0000-0002-0664-8137]en
Issued Date2026-02-28en
AbstractBackground: Chronic kidney disease (CKD) is a growing global health burden characterized by progressive renal decline, chronic inflammation, oxidative stress, and frequent sleep disturbances. Melatonin, an endogenous regulator of circadian rhythm with antioxidant and anti-inflammatory properties, has been proposed as a potential adjunctive therapy in CKD. Objectives: To evaluate the effects of oral melatonin supplementation on inflammatory markers, oxidative stress, metabolic parameters, blood pressure, and sleep quality in non-dialysis patients with CKD stages 3 - 4. Methods: In this randomized, double-blind, placebo-controlled clinical trial enrolled 73 non-dialysis patients with CKD stages 3 - 4 (glomerular filtration rate < 60 mL/min/1.73 m²). Participants were randomly assigned to receive either oral melatonin (3 mg/day) or matching placebo for 12 weeks. Serum levels of interleukin-1β (IL-1β), malondialdehyde (MDA), blood pressure, sleep quality, and routine biochemical parameters were measured at baseline and post-intervention. Results: After 12 weeks, no significant changes were observed in IL-1β or MDA levels in either group (P > 0.05). The MDA decreased in the melatonin group (-0.39 ± 9.36) and slightly increased in the placebo group (0.69 ± 4.93; between-group P = 0.313). Melatonin supplementation yielded a significant reduction in total cholesterol compared with placebo. Regarding sleep quality, both groups showed slight numerical changes, but the melatonin group exhibited a relatively more favorable trajectory, a smaller mean decline in PSQI score (-0.18 ± 0.84) compared with placebo (-0.69 ± 1.06; P = 0.047). Conclusions: Twelve-week melatonin supplementation did not significantly alter inflammatory or oxidative stress markers in stage 3 - 4 CKD but was well tolerated and demonstrated modest metabolic and sleep-related benefits. Larger and longer studies are warranted to clarify its clinical relevance and mechanistic pathways in this population.en
DOIhttps://doi.org/10.5812/jjnpp-170199en
URIhttps://brieflands.com/journals/jjnpp/articles/170199en
KeywordChronic Kidney Diseaseen
KeywordMelatoninen
KeywordInflammationen
KeywordOxidative Stressen
KeywordSleep Qualityen
PublisherBrieflandsen
TitleEffects of Oral Melatonin Supplementation on Inflammatory and Oxidative Stress Markers, Metabolic Parameters, Blood Pressure, and Sleep Quality in Patients With Stage 3 - 4 Chronic Kidney Disease: A Randomized, Double-Blind, Placebo-Controlled Trialen
TypeResearch Articleen

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