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

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.

Timeline

Start

2023-01-15

Primary completion

2023-06-03

Completion

2023-06-15

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications