Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT06508333
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT06508333
Study Brief:
Protocol Section:
NCT06508333