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

Not Applicable

Recruiting

• Conditions: Enuresis
• Interventions: Behavioral: alarm therapy; Drug: Vitamin D3

• Registration Number: NCT06508333
• Lead Sponsor: Xing Liu

Brief 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.

Study Timeline

• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-07-14
• Study First Posted: 2024-07-18
• Study Start: 2024-12-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-13
• Primary Completion: 2025-09-15
• Last Update Posted: 2025-09-18
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alarm therapy	alarm therapy	These patients will receive alarm therapy for 8 weeks
Alarm therapy combined with short-term high dose exogenous vitamin D supplementation	alarm therapy	These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) and alarm therapy for 8 weeks
Alarm therapy combined with short-term high dose exogenous vitamin D supplementation	Vitamin D3	These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) and alarm therapy for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in enuresis frequency	8 week	Change in enuresis frequency from baseline to follow-up
Response after interventions	8 weeks	Response rate: defined as a ≥50% reduction in the number of wet nights per week
Complete response after interventions	8 weeks	The rate of complete response was defined as a 100% reduction in wet nights per week.

Secondary Outcome Measures

Name	Time	Method
Change in quality of life score	8 week	The quality of life was assessed using a scale ranging from 0 to 3, where a score of 0 indicated no impact on family, social, or academic life, a score of 1 indicated occasional impact, a score of 2 indicated significant impact, and a score of 3 indicated severe impact on family, social, or academic life.
Change in vitamin D level	8 week	Change in vitamin D level from baseline to follow-up
Change in serum levels of calcium	8 weeks	Change in serum levels of calcium from baseline to follow-up
Global perception of improvement	8 week	Global perception of improvement (much better; better; about the same; worse)
Wish to receive another form of treatment?	8 week	Wish to receive another form of treatment? (YES; No)
Treatment adherence	8 week	The extent to which a patient adheres to their medication schedule, including both timing and dosage, or follows the prescribed treatment regimen
Incidence of side effects	8 week	Type and frequency of side effects during treatment

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing Municipality, China