Vitamin D Versus Desmopressin Versus Combination Therapy in Children With Primary Monosymptomatic… (NCT07292753) | Clinical Trial Compass
CompletedNot Applicable
Vitamin D Versus Desmopressin Versus Combination Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis and Vitamin D Deficiency
Egypt90 participantsStarted 2024-12-15
Plain-language summary
This randomized clinical trial evaluated three treatment approaches for children aged 6 to 12 years who had primary monosymptomatic nocturnal enuresis (night-time bedwetting) and confirmed vitamin D deficiency. Bedwetting is common in school-aged children and can affect self-esteem, social interactions, and school performance. Although desmopressin is widely used, some children do not respond adequately. Previous studies suggested that low vitamin D levels might contribute to bedwetting, raising the possibility that vitamin D supplementation could help.
In this study, eligible children were randomly assigned to one of three groups:
1. vitamin D supplementation alone,
2. desmopressin alone, or
3. a combination of vitamin D and desmopressin.
All participants were followed for up to six months. The primary aim was to compare the improvement in the number of wet nights per week among the three groups. Secondary assessments included treatment tolerability, changes in vitamin D levels, changes in serum sodium, and any treatment-related side effects.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children and adolescents aged 6 to 12 years
* Primary monosymptomatic nocturnal enuresis
* At least 2 episodes of night-time bedwetting per week for ≥3 consecutive months
* Serum 25-hydroxyvitamin D level \<20 ng/mL
* Normal kidney function
* Normal serum sodium level
* Absence of daytime lower urinary tract symptoms (urgency, frequency, dysuria)
* Informed consent from parent or guardian and assent from the child when appropriate
Exclusion Criteria:
* Non-monosymptomatic nocturnal enuresis (daytime storage or voiding symptoms)
* Congenital urinary tract anomalies (e.g., meatal stenosis, hypospadias, epispadias)
* Urinary tract infection until culture becomes negative
* Neurological abnormalities, including suspected neurogenic bladder
* Endocrine diseases such as diabetes mellitus or hyperthyroidism
* Congestive heart failure or significant cardiac disease
* Prior or current use of vitamin D supplementation
* Serum sodium below normal range
* Chronic systemic illness
* Any condition judged by investigators to interfere with study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in number of wet nights per week at 3 months
Timeframe: Baseline and 3 months after initiation of therapy