Overview

Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children

Status:
Recruiting

Trial end date:
2024-12-30

Target enrollment:
0

Participant gender:
All

Summary

This prospective, randomized, 3-arms, parallel-design, controlled clinical trial was 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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Xing Liu

Treatments:

Cholecalciferol
Solifenacin Succinate
Vitamin D

Criteria

Inclusion Criteria:(1) 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). (2) Children with a serum vitamin D level
of less than 35 ng/ml as indicated by the laboratory result. (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.

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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)Any condition/treatment
that could cause urinary symptoms or interfere with assessment of efficacy parameters
assessed by researchers. (11)Unwillingness to participate in this study or poor compliance
with follow-up.

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