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Efficacy and Safety of Short-Term High-Dose Vitamin D Supplementation Combined with Enuresis Alarms for Treating Primary Nocturnal Enuresis in Children: A Prospective, Randomized, Controlled, Single-Center Clinical Trial

Efficacy and Safety of Short-Term High-Dose Vitamin D Supplementation Combined with Enuresis Alarms for Treating Primary Nocturnal Enuresis in Children: A Prospective, Randomized, Controlled, Single-Center Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100186
Enrollment
Unknown
Registered
2025-04-03
Start date
2024-06-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary nocturnal enuresis

Interventions

Vitamin D supplementation combined with enuresis alarms group:Vitamin D supplementation combined with enuresis alarms
Enuresis alarms group:Enuresis alarms

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Children over 5 years of age diagnosed with primary nocturnal enuresis (PNE) who are attending the outpatient clinic of the Department of Urology at the Affiliated Children's Hospital of Chongqing Medical University. The diagnosis is based on the criteria set by the International Children's Continence Society (ICCS) and confirmed by a qualified physician. 2. Laboratory results from our hospital indicate that the child's serum vitamin D level is below 35 ng/mL. 3. The child (or guardian) has been fully informed about the nature of the study, understands the study protocol, is capable of ensuring compliance, and has signed an informed consent form. 4. The child (or guardian) is in good psychological health, shows no significant cognitive or communication impairments, and is able to accurately report the child's symptoms and any potential adverse reactions during the treatment.

Exclusion criteria

Exclusion criteria: 1. Presence of other urological malformations or serious medical conditions (e.g., hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urological tumors, urinary stones, bladder and urethral injuries, etc.); 2. Comorbid neurological disorders (e.g., epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, autism spectrum disorder, attention deficit hyperactivity disorder, etc.); 3. Comorbid endocrine disorders (e.g., diabetes mellitus, hyperthyroidism, etc.); 4. Presence of severe heart disease, abnormal liver and kidney function, lung disease, skeletal deformities, severe gastrointestinal disorders, or genetic metabolic diseases; 5. Conditions leading to sleep apnea syndrome (e.g., adenoid hypertrophy, tonsillar hypertrophy, deviated nasal septum, abnormal jaw or maxillofacial development, central sleep apnea, etc.); 6. History of gastrointestinal or urological surgeries; 7. Chronic constipation or dry stools; 8. Use of anticonvulsants, antiepileptic drugs, hormones, or anti-tuberculosis medications; 9. History of hypercalcemia and hyperphosphatemia associated with renal rickets; 10. History of unexplained hematuria or urinary tract infections within the past year; 11. Known allergy or hypersensitivity to vitamin D preparations; 12. Participation in other clinical trials at the time of enrollment or during follow-up; 13. Individuals unwilling to participate or with poor follow-up compliance.

Design outcomes

Primary

MeasureTime frame
Change in mean enuresis frequency;

Secondary

MeasureTime frame
Nocturnal urine volume;Maximum daytime urine volume;Children's sleep disorder scores;Quality of life scores;Change in pediatric lower urinary tract symptom score;Overall Treatment Satisfaction of Pediatric Patients (and Their Families);Treatment Adherence of Pediatric Patients (and Their Families);

Countries

China

Contacts

Public ContactXing Liu

Children's Hospital of Chongqing Medical University

liux@hospital.cqmu.edu.cn+86 15102376465

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026