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

February 19, 2026 updated by: Xing Liu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

262

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400000
        • Children's Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Children aged 5-18 years diagnosed with PMNE-defined as intermittent urinary incontinence during sleep in a children who are never dry for more than 6 months and have no other lower urinary tract symptoms-according to the latest International Children's Continence Society guidelines, presenting at outpatient urology clinics.
  • Serum vitamin D level below 30 ng/mL.
  • Written informed consent obtained from each participant and their guardian.
  • Adequate psychological and cognitive function, no communication barriers, and ability to accurately report symptoms and potential adverse reactions during treatment.

Exclusion Criteria

  • Urological malformations or serious urological disease, such as hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urinary tumors, urinary stones, or bladder/urethral injuries.
  • Neurological disorders, including epilepsy, spinal cord injury or dysplasia, spinal embolism syndrome, multiple sclerosis, autism spectrum disorder, or attention-deficit/hyperactivity disorder.
  • Endocrine diseases, such as diabetes mellitus or hyperthyroidism.
  • Severe systemic disease, including significant cardiac disease, renal or hepatic insufficiency, pulmonary disease, bone deformities, gastrointestinal disorders, or inherited metabolic disorders.
  • Conditions predisposing to sleep apnea, such as adenoid or tonsillar hypertrophy, deviated nasal septum, craniofacial abnormalities, or central sleep apnea.
  • History of gastrointestinal or urological surgery.
  • Use of anticonvulsant, antiepileptic, corticosteroid, or anti-tuberculosis medications.
  • History of hypercalcemia, hyperphosphatemia, or renal rickets.
  • Unexplained hematuria or urinary tract infection within the past year.
  • Allergy to vitamin D formulations.
  • Concurrent participation in other clinical studies.
  • Unwillingness to participate or poor anticipated follow-up compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alarm therapy
These patients will receive alarm therapy for 8 weeks
Behavioral: alarm therapy
These patients will receive alarm therapy for 8 weeks.
Experimental: Alarm therapy combined with short-term high dose exogenous vitamin D supplementation
These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) and alarm therapy for 8 weeks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response after interventions
Time Frame: 8 weeks
Response rate: defined as a ≥50% reduction in the number of wet nights per week
8 weeks
Complete response after interventions
Time Frame: 8 weeks
The rate of complete response was defined as a 100% reduction in wet nights per week.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life score
Time Frame: 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.
8 week
Change in vitamin D level
Time Frame: 8 week
Change in vitamin D level from baseline to follow-up
8 week
Global perception of improvement
Time Frame: 8 week
Global perception of improvement (much better; better; about the same; worse)
8 week
Wish to receive another form of treatment?
Time Frame: 8 week
Wish to receive another form of treatment? (YES; No)
8 week
Treatment adherence
Time Frame: 8 week
The extent to which a patient adheres to their medication schedule, including both timing and dosage, or follows the prescribed treatment regimen
8 week
Incidence of side effects
Time Frame: 8 week
Type and frequency of side effects during treatment
8 week
Change in serum levels of calcium
Time Frame: 8 weeks
Change in serum levels of calcium from baseline to follow-up
8 weeks
Change in enuresis frequency
Time Frame: 8 weeks
Change in enuresis frequency from baseline to follow-up
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xing Liu

Investigators

  • Study Director: Xing Liu, Doctor, Children's Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

March 31, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

July 14, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Apart from the participant's personal information.

IPD Sharing Time Frame

8 weeks

IPD Sharing Access Criteria

Apart from the participant's personal information

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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