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

NCT05709990 | Completed DMC

• 1 other identifier: 2022515
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Change in voiding frequency

  Change in voiding frequency as documented in the bladder diaries (voids/d) from baseline to the followup

  8 weeks

Secondary Outcomes (8)

• Change in mean urgency score

  8 weeks

• Change in max urgency score

  8 weeks

• Change in pediatric lower urinary tract symptom score

  8 weeks

• Change in quality of life score

  8 weeks

• Change in mean nocturia frequency, episodes/night

  8 weeks

Study Arms (3)

High dose vitamin D supplementation (combined with standard urotherapy)

EXPERIMENTAL

These patients will receive high dose vitamin D supplementation (more than 2000IU daily) and behavioral therapy for 8 weeks

Drug: Vitamin D3

Solifenacin succinate group (combined with standard urotherapy)

ACTIVE COMPARATOR

These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks

Drug: Solifenacin Succinate 5 MG Oral Tablet [Vesicare]

standard urotherapy group

ACTIVE COMPARATOR

These patients will receive behavioral therapy alone for 8 weeks.

Behavioral: Standard urotherapy

Interventions

Solifenacin Succinate 5 MG Oral Tablet [Vesicare] DRUG

These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.

Also known as: standard urotherapy

Solifenacin succinate group (combined with standard urotherapy)

Vitamin D3 DRUG

These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.

Also known as: standard urotherapy

High dose vitamin D supplementation (combined with standard urotherapy)

Standard urotherapy BEHAVIORAL

These patients will receive standard urotherapyfor 8 weeks.

standard urotherapy group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Xing Liu: lead

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (6)

• Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Vande Walle J, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society. J Urol. 2014 Jun;191(6):1863-1865.e13. doi: 10.1016/j.juro.2014.01.110. Epub 2014 Feb 4.

  PMID: 24508614 BACKGROUND

• Franco I. Overactive bladder in children. Nat Rev Urol. 2016 Sep;13(9):520-32. doi: 10.1038/nrurol.2016.152. Epub 2016 Aug 17.

  PMID: 27530266 BACKGROUND

• Abrams P, Swift S. Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis. Eur Urol. 2005 Sep;48(3):483-7. doi: 10.1016/j.eururo.2005.06.007.

  PMID: 16005564 BACKGROUND

• Yuan P, Wang T, Li H, Lan R, Li M, Liu J. Systematic Review and Meta-Analysis of the Association between Vitamin D Status and Lower Urinary Tract Symptoms. J Urol. 2021 Jun;205(6):1584-1594. doi: 10.1097/JU.0000000000001441. Epub 2020 Nov 18.

  PMID: 33207134 BACKGROUND

• Markland AD, Vaughan CP, Huang AJ, Kim E, Bubes VY, Tangpricha V, Buring JR, Lee IM, Cook NR, Manson JE, Grodstein F. Effect of Vitamin D Supplementation on Overactive Bladder and Urinary Incontinence Symptoms in Older Men: Ancillary Findings From a Randomized Trial. J Urol. 2023 Jan;209(1):243-252. doi: 10.1097/JU.0000000000002942. Epub 2022 Sep 6.

  PMID: 36067369 BACKGROUND

• Brustad N, Yousef S, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL. Safety of High-Dose Vitamin D Supplementation Among Children Aged 0 to 6 Years: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Apr 1;5(4):e227410. doi: 10.1001/jamanetworkopen.2022.7410.

  PMID: 35420658 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate; Tablets; Cholecalciferol

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Xing Liu, Doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: outcome evaluators, and statisticians were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Urology, Children's Hospital of Chongqing Medical University

Model Details: The 3 groups will be treated at the same time

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 2, 2023
• Study Start: January 15, 2023
• Primary Completion: June 3, 2023
• Study Completion: June 15, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 8 weeks
• Access Criteria: Apart from the participant's personal information

Locations

CN (1)