NCT06508333

Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis

Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis: A Prospective, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Xing Liu · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, two-arm, parallel-design controlled clinical trial aims to determine whether high-dose vitamin D supplementation combined with alarm therapy improves outcomes in children with primary monosymptomatic nocturnal enuresis compared to alarm therapy alone.

Detailed description

Nocturnal enuresis (NE) is characterized by recurrent involuntary urination during sleep in children aged 5 years and older, persisting for over three months with at least two episodes per week. This condition, resulting from the child's inability to awaken from sleep, exhibits a prevalence rate ranging from 4.8% to 15.2%, which notably declines with age. Moreover, NE significantly impacts the psychological well-being and overall quality of life of affected individuals. The primary treatments for NE include desmopressin acetate (DDAVP) and behavioral interventions (BI). While these modalities offer therapeutic benefits, their implementation is often prolonged and fraught with challenges, including adverse drug reactions and a high rate of symptom recurrence after treatment discontinuation. These factors complicate adherence for both patients and their families. Patients with NE are more likely to suffer from vitamin D deficiency. This study aims to determine the effect of vitamin D supplementation as an adjunctive therapy to alarm therapy in the treatment of primary monosymptomatic nocturnal enuresis(PMNE). Eligible patients aged 5-18 years with a diagnosis of NE will be randomly assigned to receive either high-dose vitamin D supplementation combined with alarm therapy or alarm therapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptom severity will be assessed at baseline and follow-up, along with other sociodemographic data. This study will provide more information on the role of vitamin D supplementation in managing PMNE.

Conditions

• Enuresis

Interventions

Type	Name	Description
BEHAVIORAL	alarm therapy	These patients will receive alarm therapy for 8 weeks.
DRUG	Vitamin D3	These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) (combined with alarm therapy) for 8 weeks.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-03-31
• Completion: 2025-05-31
• First posted: 2024-07-18
• Last updated: 2026-02-23

Locations

1 site across 1 country: China