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Efficacy and safety of vitamin D supplementation in the treatment of pediatric overactive bladder syndrome: a prospective, randomized, controlled, single-center clinical study

Efficacy and safety of vitamin D supplementation in the treatment of pediatric overactive bladder syndrome: a prospective, randomized, controlled, single-center clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067454
Enrollment
Unknown
Registered
2023-01-09
Start date
2023-01-20
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Overactive Bladder Syndrome

Interventions

Vitamin D supplementation group:Supplementation with oral vitamin D preparations
Standard urotherapy group:Dietary instruction, behavioral training, bladder training

Sponsors

Department of Urology, Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) Children older than 4 years of age with a diagnosis of OAB seen at the outpatient urology clinic of the Children's Hospital of Chongqing Medical University (diagnosis follows the latest ICCS recommendations). (2) Children with a serum vitamin D level of less than 35 ng/ml as indicated by the laboratory results of our hospital. (3) The child's guardian has been informed of the nature of the study, understands the provisions in the protocol, can ensure compliance, and has signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those with a combination 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.). (2) Combined neurological disorders (e.g. epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, autism spectrum disorder, etc.) (3) Those with a combination of severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders (4) Those with a history of gastrointestinal surgery and urinary tract surgery (5) Those with dry stools and chronic constipation. (6) Those who are taking anticonvulsant and antiepileptic drugs, hormones, anti-tuberculosis drugs. (7) Previous history of hypercalcemia, hyperphosphatemia with renal rickets. (8) History of unexplained haematuria and urinary tract infection within the last 1 year. (9) History of allergy or allergic disease to vitamin D preparations. (10) Participation in other clinical studies at the time of consultation or during follow-up of other clinical studies. (11) Unwillingness to participate in this study or poor compliance with follow-up.

Design outcomes

Primary

MeasureTime frame
pediatric lower urinary tract symptom score;Overall symptom improvement score;bladder diary;Urinary frequency, urinary urgency, urinary incontinence, maximum urinary output;Maximum urinary urgency score;urinary urgency score;Drug-related adverse reactions;Serum vitamin D levels;

Countries

China

Contacts

Public ContactXing Liu

Children's Hospital of Chongqing Medical University

chs_1900@163.com15123010925

Outcome results

None listed

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