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

• Sponsor: Xing Liu (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05709990
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 23.5
• Patients Per Site Per Month: 12.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Solifenacin Succinate 5 MG Oral Tablet [Vesicare]; Drug: Vitamin D3; Behavioral: Standard urotherapy	N/A

Detailed Description

Overactive bladder(OAB), characterized as urinary urgency accompanied in many instances by frequency and sometimes nocturia, with or without urinary incontinence, in the absence of urinary tract infection or other documented pathology, is a common clinical entity in pediatric urology. The majority of patients with OAB do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia, which has been termed OAB dry. Currently, standard urotherapy is proposed as the first-line therapeutic options and adjunctive anticholinergics are usually used when urotherapy alone failed. Behavioral therapy often fail to achieve satisfied symptom control as children's poor compliance. In addition,adverse side effects such as dry mouth, constipation, gastro-oesophageal reflux result in early pharmacologic treatment discontinuation.

It was informed that patients with OAB are more likely to suffer from vitamin D deficiency. The aim of the study is to determine the effect of vitamin D supplementation as an adjunctive therapy to behavioral therapy in the treatment of OAB dry. Eligible patients aged 5-18 years with a diagnosis of OAB dry will be randomly assigned into three groups to receive high dose vitamin D supplementation (combined with standard urotherapy ) , solifenacin (combined with standard urotherapy ) or standard urotherapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptoms severity will be assessed at baseline and followup. All the other sociodemographic data will be also assessed. The study will give more information on the application of vitamin D supplementation in the management of OAB dry.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The 3 groups will be treated at the same timeThe 3 groups will be treated at the same time
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Participants, practitioners, outcome evaluators, and statisticians were blinded.
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial
• Actual Study Start Date: Jan 15, 2023
• Anticipated Primary Completion Date: May 15, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High dose vitamin D supplementation (combined with standard urotherapy) These patients will receive high dose vitamin D supplementation (more than 2000IU daily) and behavioral therapy for 8 weeks	Drug: Vitamin D3; These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.; Other Names: standard urotherapy
Active Comparator: Solifenacin succinate group (combined with standard urotherapy) These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks	Drug: Solifenacin Succinate 5 MG Oral Tablet [Vesicare]; These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.; Other Names: standard urotherapy
Active Comparator: standard urotherapy group These patients will receive behavioral therapy alone for 8 weeks.	Behavioral: Standard urotherapy; These patients will receive standard urotherapyfor 8 weeks.

Outcome Measures

Primary Outcome Measures

1. Change in voiding frequency [8 weeks]

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

2. Change in urgency score [8 weeks]

   Change in voiding frequency as documented from baseline to the followup

Secondary Outcome Measures

1. Change in pediatric lower urinary tract symptom score [8 weeks]

   Change in pediatric lower urinary tract symptom score from baseline to the followup

2. Change in mean nocturia frequency, episodes/night [8 weeks]

   Change in mean nocturia frequency from baseline to the followup

3. Change in vitamin D level [8 weeks]

   Change in vitamin D level from baseline to the followup

4. Global perception of improvement [8 weeks]

   Global perception of improvement (much better; better; about the same; worse)

5. Wish to receive another form of treatment? [8 weeks]

   Wish to receive another form of treatment? (YES; No)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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. Written informed consent was obtained from participants and their parents. -

Exclusion Criteria:

1. 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.).

2. 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.) .

3. Those with acomorbidity 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 chronic constipation.

6. Those taking anticonvulsant and antiepileptic drugs, hormones, anti-tuberculosis drugs.

7. Those have a previous history of hypercalcemia, hyperphosphatemia with renal rickets.

8. Those have a history of haematuria and urinary tract infection within the last 1 year.

9. Those have a history of allergy or allergic disease to vitamin D preparations.

10. Those Participate in other clinical studies at the time of consultation or during the follow-up of other clinical studies.

11. Any condition that could cause urinary symptoms or interfere with assessment of efficacy parameters.

12. Those unwilling to participate in this study. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400000

Sponsors and Collaborators

• Xing Liu

Investigators

• Study Director: Xing Liu, Doctor, Children's Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Xing Liu, Director of Urology, Children's Hospital of Chongqing Medical University, Children's Hospital of Chongqing Medical University
• ClinicalTrials.gov Identifier: NCT05709990
• Other Study ID Numbers: 2022515
• First Posted: Feb 2, 2023
• Last Update Posted: Feb 3, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Vitamin D; Cholecalciferol; Solifenacin Succinate

Study Results

No Results Posted as of Feb 3, 2023