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

Abstract

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 2-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 levels below 30 ng/mL were randomly assigned to receive either 8 weeks of VDS (vitamin D3 soft capsules, 2400 IU/d) 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 scores, and treatment satisfaction. Safety was assessed by recording treatment-emergent adverse events.

Results:

A total of 304 children were assessed for eligibility, of whom 262 (130 in the VDS + EA group and 132 in the EA group) were included in the final analysis. Compared with the EA group, the VDS + EA group showed higher response rates (RR 1.22; 95% CI 1.01-1.49; P = .04), complete response rates (RR 1.54; 95% CI 1.10-2.15; P = .01), a greater reduction in weekly wet nights (median difference, 1; 95% CI, 0-2; P = .003), and greater improvements in quality of life and treatment satisfaction. No statistically significant difference in the risk of treatment-emergent adverse events was observed between groups.

Conclusions:

High-dose VDS combined with EA was effective and well tolerated for treating PMNE in children with vitamin D insufficiency, supporting its potential as a promising therapeutic approach.

Ye Z, Luo X, Chen H, Zhang Q, Li C, Zhang Z, et al. 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. Journal of Urology [Internet]. 2026 Aug 1 [cited 2026 Aug 7];216(2):182–93. Available from: https://doi.org/10.1097/JU.0000000000005071