Adjunctive Use of Melatonin in Pediatric Urinary Tract Infections: A Randomized Controlled Trial
Journal of Pediatric Nephrology,
Vol. 13 No. 1 (2025),
12 Ordibehesht 2026,
https://doi.org/10.22037/jpn.v13i1.48292
Background and Aim: Urinary tract infections (UTIs) are among the most common
bacterial infections in children and adolescents. Despite standard antibiotic therapy, symptom
resolution can be delayed due to ongoing inflammation. Melatonin, a neurohormone with
known antioxidant and immunomodulatory properties, may offer therapeutic benefits in this
context. This study aimed to evaluate the clinical efficacy of adjunctive melatonin therapy in
pediatric patients with UTIs, focusing on symptom resolution and potential anti-inflammatory
effects.
Methods: In this double-blind, randomized, placebo-controlled trial, 100 children aged
4–18 years with confirmed UTI and concurrent sleep disturbances were assigned to receive
either melatonin (3 mg/day) plus antibiotics (intervention group) or antibiotics plus placebo
(control group) for 10 days. Primary outcomes included time to resolution of fever, dysuria,
abdominal pain, urinary frequency, and incontinence.
Results: Baseline characteristics were similar between groups. The melatonin group showed
significantly faster resolution of fever (1.3±0.49 vs 3.7±0.69 days, P=0.001), abdominal pain
(1.2±0.54 vs 3.62±0.67 days, P=0.001), and dysuria (1.5±0.57 vs 3.6±0.67 days, P=0.001).
No significant differences were observed in urinary frequency or incontinence outcomes. No
adverse effects related to melatonin were reported.
Conclusion: Adjunctive melatonin therapy appears to accelerate the resolution of key UTI
symptoms in children when combined with antibiotics, likely due to its anti-inflammatory
and antioxidant properties. These findings suggest a potential role for melatonin in pediatric
UTI management and warrant further investigation in larger, multicenter trials.