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
| Author | Shadi Ziaie | en |
| Author | Fatemeh Pourrezagholie | en |
| Author | Aylar Nadiri Niri | en |
| Author | Behnam Mahdavi | en |
| Author | Mohammad Abbasinazari | en |
| Author | Roja Asadpour | en |
| Orcid | Shadi Ziaie [0000-0002-4358-470X] | en |
| Orcid | Fatemeh Pourrezagholie [0000-0001-7534-8309] | en |
| Orcid | Roja Asadpour [0000-0002-0664-8137] | en |
| Issued Date | 2026-02-28 | en |
| Abstract | Background: 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 |
| DOI | https://doi.org/10.5812/jjnpp-170199 | en |
| URI | https://brieflands.com/journals/jjnpp/articles/170199 | en |
| Keyword | Chronic Kidney Disease | en |
| Keyword | Melatonin | en |
| Keyword | Inflammation | en |
| Keyword | Oxidative Stress | en |
| Keyword | Sleep Quality | en |
| Publisher | Brieflands | en |
| Title | 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 | en |
| Type | Research Article | en |
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