Efficacy and Safety of High-Dose Vitamin D Supplementation Combined with an Enuresis Alarm vs Alarm Alone in Children with Primary Monosymptomatic Nocturnal Enuresis: A Randomized Clinical Trial.

PURPOSE: This study evaluated the efficacy and safety of high-dose vitamin D supplementation (VDS) combined with enuresis alarm (EA) therapy in children with primary monosymptomatic nocturnal enuresis (PMNE). MATERIALS AND METHODS: A two-arm randomized clinical trial was conducted at a tertiary center in China between December 2024 and May 2025. Children with PMNE and serum 25-hydroxyvitamin D (25(OH)D) levels below 30 ng/mL were randomly assigned to receive either 8 weeks of VDS (vitamin D3 soft capsules, 2400 IU/day) plus EA (VDS + EA group) or EA (EA group). The primary outcome was treatment response. Secondary outcomes included change in weekly frequency of wet nights, quality-of-life (QoL) scores and treatment satisfaction. Safety was assessed by recording treatment-emergent adverse events (TEAEs). No statistically significant difference in the risk of TEAEs was observed between groups. CONCLUSIONS: High-dose VDS combined with EA was effective and well tolerated for treating PMNE in children, supporting its potential as a promising therapeutic approach.