Status:
RECRUITING
Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis
Lead Sponsor:
Xing Liu
Conditions:
Enuresis
Eligibility:
All Genders
5-18 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06508333
Start Date
December 1 2024
End Date
October 1 2025
Last Update
September 18 2025
Active Locations (1)
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1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000