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NCT05709990
Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children
Conditions: Overactive Bladder
Sex: All
Ages: 5 Years – 18 Years
Phase: NA
Enrollment: 300
Sponsor: Xing Liu
Location: China
Summary
This prospective, randomized, 3-arms, parallel-design, controlled clinical trial is conducted to determine whether high dose vitamin D supplementation (combined with standard urotherapy ) improves outcomes, compared with solifenacin (combined with standard urotherapy ) ,and standard urotherapy alone in children with OAB dry.
Eligibility Criteria
Inclusion Criteria:Children older than 5 years of age with a diagnosis of OAB dry (do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia) seen at the outpatient urology clinics (diagnosis follows the latest International Children's Continence Society recommendations).Children with a serum vitamin D level of less than 35 ng/ml as indicated by the laboratory result.Written informed consent was obtained from participants and their parents.
-Exclusion Criteria:Those with a comorbidity of other urological abnormalities or serious diseases (e.g.
hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urological tumours, urinary stones, bladder and urethral injuries, etc.).Those with a comorbidity of neurological disorders (e.g.
epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, autism spectrum disorder, etc.) .Those with acomorbidity of severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders.Those with a history of gastrointestinal surgery and urinary tract surgery.Those with chronic constipation.Those taking anticonvulsant and antiepileptic drugs, hormones, anti-tuberculosis drugs.Those have a previous history of hypercalcemia, hyperphosphatemia with renal rickets.Those have a history of haematuria and urinary tract infection within the last 1 year.Those have a history of allergy or allergic disease to vitamin D preparations.Those Participate in other clinical studies at the time of consultation or during the follow-up of other clinical studies.Any condition that could cause urinary symptoms or interfere with assessment of efficacy parameters.Those unwilling to participate in this study.
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Source: ClinicalTrials.gov (NCT05709990). StuddyBuddy aggregates publicly available trial information.