The clinical trial, led by Leila Manzouri from the Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Iran, assessed whether melatonin supplementation could benefit sleep, quality of life, and blood pressure in patients undergoing maintenance hemodialysis. Poor sleep quality and reduced physical well-being are common in this population, and previous research has suggested that melatonin may play a role in improving such outcomes in other chronic illnesses.
The trial was designed as a double-blind, randomized study involving 82 patients, equally divided into two groups: one receiving melatonin and the other receiving a placebo. Participants received either 3 mg of oral melatonin or a placebo each night for six weeks. Before and after the intervention, participants completed the Pittsburgh Sleep Quality Index (PSQI) and the Kidney Disease Quality of Life Questionnaire-Short Form (KDQOL-SF). Blood pressure readings—both systolic and diastolic—were recorded during dialysis sessions by trained nursing staff.
The study led to the following notable findings:
- At baseline, there were no significant differences between the melatonin and placebo groups in terms of age, gender distribution, body mass index, duration of hemodialysis, blood pressure, sleep quality, or quality-of-life scores.
- The average age was 48.97 years in the melatonin group and 50.07 years in the placebo group.
- By the end of the study, melatonin supplementation significantly improved sleep quality compared to placebo, with PSQI scores notably better in the melatonin group.
- KDQOL-SF results showed significant differences in the sleep domain and improvements in physical function and energy levels, indicating potential benefits for certain aspects of quality of life in hemodialysis patients.
- No significant changes were observed in systolic or diastolic blood pressure between the groups after the intervention.
- Blood pressure measurements were taken only during dialysis sessions, which may not reflect full-day variations; researchers suggested future studies use 24-hour ambulatory monitoring for more precise evaluation.
The authors concluded that while melatonin offers clear benefits for sleep and some quality-of-life measures, its impact on blood pressure remains uncertain. They suggest that longer-term studies are needed to determine whether sustained melatonin use could lead to more pronounced cardiovascular effects in hemodialysis patients.
"The study adds to growing evidence supporting the potential role of melatonin in improving well-being in patients with chronic kidney disease, particularly for addressing sleep disturbances—an often-overlooked yet important aspect of patient care," the authors wrote.
Reference:
Larki, R.A., Iranmanesh, A., Gholami, D. et al. The effect of oral melatonin on the quality of life, sleep and blood pressure of hemodialysis patients: a randomized clinical trial. BMC Nephrol 26, 451 (2025). https://doi.org/10.1186/s12882-025-04387-7
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