Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508333
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis A Prospective Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unauthorized registration by a non-account owner permission not granted The registration number needs to be withdrawn
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective randomized two-arm parallel-design controlled clinical trial aims to determine whether high-dose vitamin D supplementation combined with alarm therapy improves outcomes in children with nocturnal enuresis compared to alarm therapy alone
Detailed Description:
Nocturnal enuresis NE is characterized by recurrent involuntary urination during sleep in children aged 5 years and older persisting for over three months with at least two episodes per week This condition resulting from the childs inability to awaken from sleep exhibits a prevalence rate ranging from 48 to 152 which notably declines with age Moreover NE significantly impacts the psychological well-being and overall quality of life of affected individuals The primary treatments for NE include desmopressin acetate DDAVP and behavioral interventions BI While these modalities offer therapeutic benefits their implementation is often prolonged and fraught with challenges including adverse drug reactions and a high rate of symptom recurrence after treatment discontinuation These factors complicate adherence for both patients and their families
Patients with NE are more likely to suffer from vitamin D deficiency This study aims to determine the effect of vitamin D supplementation as an adjunctive therapy to alarm therapy in the treatment of NE Eligible patients aged 5-18 years with a diagnosis of NE will be randomly assigned to receive either high-dose vitamin D supplementation combined with alarm therapy or alarm therapy alone Serum levels of 25OHD will be measured at baseline Symptom severity will be assessed at baseline and follow-up along with other sociodemographic data This study will provide more information on the role of vitamin D supplementation in managing NE
Patients with NE are more likely to suffer from vitamin D deficiency This study aims to determine the effect of vitamin D supplementation as an adjunctive therapy to alarm therapy in the treatment of NE Eligible patients aged 5-18 years with a diagnosis of NE will be randomly assigned to receive either high-dose vitamin D supplementation combined with alarm therapy or alarm therapy alone Serum levels of 25OHD will be measured at baseline Symptom severity will be assessed at baseline and follow-up along with other sociodemographic data This study will provide more information on the role of vitamin D supplementation in managing NE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None