Nocturnal EnuresisNCT07292753
Vitamin D Versus Desmopressin Versus Combination Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis and Vitamin D Deficiency
A study testing Vitamin D and Desmopressin in people with Nocturnal Enuresis and Vitamin D Deficiency, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Nocturnal Enuresis, Vitamin D Deficiency
- What is being tested?
- Vitamin D and Desmopressin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Vitamin D Supplementation Versus Desmopressin Versus Their Combination in the Treatment of Primary Monosymptomatic Nocturnal Enuresis in Children With Vitamin D Deficiency: A Randomized Clinical Trial
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:
Read more
- vitamin D supplementation alone,
- desmopressin alone, or
- 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.
- Conditions
- Nocturnal Enuresis, Vitamin D Deficiency
- Being tested
- Vitamin D, Desmopressin
- Keywords
- Primary monosymptomatic nocturnal enuresis, Bedwetting, Pediatric nocturnal enuresis, Desmopressin, Vitamin D supplementation, Vitamin D deficiency, Pediatric urology, Children 6-12 years, Randomized clinical trial
- Medical subject headings
- Nocturnal Enuresis, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Oral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis.
DesmopressinDrug
Oral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Monotherapy | Experimental | Participants receive vitamin D supplementation at a dose of 2000 IU orally once daily for 6-12 weeks, followed by a maintenance dose of 600 IU orally once daily for the remainder of the 6-month treatment period. Receives: Drug: Vitamin D |
| Desmopressin Monotherapy | Active comparator | Participants receive desmopressin 0.2 mg orally once daily at bedtime for the full 6-month treatment period. Dose adjustments follow standard pediatric nocturnal enuresis guidance if needed. Receives: Drug: Desmopressin |
| Combination Therapy (Vitamin D + Desmopressin) | Experimental | Participants receive vitamin D supplementation (2000 IU orally once daily for 6-12 weeks, then 600 IU daily) combined with desmopressin 0.2 mg orally once daily at bedtime for a total of 6 months. Receives: Drug: Vitamin D; Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of wet nights per week at 3 months
Mean change in the number of nocturnal enuresis (bedwetting) episodes per week from baseline to 3 months after starting treatment, comparing the three groups (vitamin D alone, desmopressin alone, and combination therapy).
Measured: Baseline and 3 months after initiation of therapy
Secondary outcomes (9)
Change in number of wet nights per week at 6 months
Mean change in the number of nocturnal enuresis episodes per week from baseline to 6 months after starting treatment, comparing the three treatment groups.
Measured: Baseline and 6 months after initiation of therapy
Proportion of patients with complete response at 3 and 6 months
Percentage of participants who achieve complete response, defined as 0 wet nights per week compared with baseline.
Measured: 3 months and 6 months after initiation of therapy
Proportion of patients with partial response at 3 and 6 months
Percentage of participants who achieve partial response, defined as a ≥50% reduction in the number of wet nights per week compared with baseline.
Measured: 3 months and 6 months after initiation of therapy
Change in serum sodium level
Mean change in serum sodium concentration from baseline to follow-up visits and proportion of patients developing hyponatremia in each treatment group.
Measured: Baseline, 1 week, 1 month, 3 months, and 6 months after initiation of desmopressin therapy
Change in serum 25-hydroxyvitamin D level
Mean change in serum 25(OH) vitamin D concentration from baseline to follow-up visits in each treatment group.
Measured: Baseline, 1 month, 3 months, and 6 months after initiation of therapy
Incidence of hyponatremia
Number and percentage of participants who develop hyponatremia (serum sodium below normal range) during the study period.
Measured: Baseline to 6 months after initiation of therapy
Incidence of headache
Number and percentage of participants reporting headache that begins after treatment initiation and is considered treatment-related.
Measured: Baseline to 6 months
Incidence of gastrointestinal symptoms
Number and percentage of participants reporting nausea, abdominal discomfort, or other gastrointestinal symptoms considered related to treatment.
Measured: Baseline to 6 months
Incidence of polyuria
Number and percentage of participants who develop polyuria or clinically significant increase in urine output associated with therapy.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start15 Dec 2024
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel-group randomized trial comparing vitamin D alone, desmopressin alone, and their combination in children with primary monosymptomatic nocturnal enuresis and vitamin D deficiency.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Magdy Ibrahim Mohammed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292753
- Sponsor's protocol ID
- FMASU MS 175/2026
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the study results may be shared with qualified researchers upon reasonable request. Shared data will include variables necessary to confirm the primary and secondary outcome analyses. No information that could identify participants will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D Supplementation Versus Desmopressin Versus Their Combination in the Treatment of Primary Monosymptomatic Nocturnal Enuresis in Children With Vitamin D Deficiency: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07292753
- Acronym / sponsor ID
- FMASU MS 175/2026
- Conditions
- Nocturnal Enuresis, Vitamin D Deficiency
- Keywords
- Primary monosymptomatic nocturnal enuresis, Bedwetting, Pediatric nocturnal enuresis, Desmopressin, Vitamin D supplementation, Vitamin D deficiency, Pediatric urology, Children 6-12 years
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- vitamin D supplementation alone,
- desmopressin alone, or
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm parallel-group randomized trial comparing vitamin D alone, desmopressin alone, and their combination in children with primary monosymptomatic nocturnal enuresis and vitamin D deficiency.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Monotherapy | Experimental | Drug: Vitamin DParticipants receive vitamin D supplementation at a dose of 2000 IU orally once daily for 6-12 weeks, followed by a maintenance dose of 600 IU orally once daily for the remainder of the 6-month treatment period. |
| Desmopressin Monotherapy | Active comparator | Drug: DesmopressinParticipants receive desmopressin 0.2 mg orally once daily at bedtime for the full 6-month treatment period. Dose adjustments follow standard pediatric nocturnal enuresis guidance if needed. |
| Combination Therapy (Vitamin D + Desmopressin) | Experimental | Drug: Vitamin D, Drug: DesmopressinParticipants receive vitamin D supplementation (2000 IU orally once daily for 6-12 weeks, then 600 IU daily) combined with desmopressin 0.2 mg orally once daily at bedtime for a total of 6 months. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DOral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis. | Drug | Combination Therapy (Vitamin D + Desmopressin), Vitamin D Monotherapy |
| DesmopressinOral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children. | Drug | Combination Therapy (Vitamin D + Desmopressin), Desmopressin Monotherapy |
Primary outcome
Change in number of wet nights per week at 3 months
Time frame: Baseline and 3 months after initiation of therapy
Mean change in the number of nocturnal enuresis (bedwetting) episodes per week from baseline to 3 months after starting treatment, comparing the three groups (vitamin D alone, desmopressin alone, and combination therapy).
9 secondary outcomes
Change in number of wet nights per week at 6 months
Time frame: Baseline and 6 months after initiation of therapy
Proportion of patients with complete response at 3 and 6 months
Time frame: 3 months and 6 months after initiation of therapy
Proportion of patients with partial response at 3 and 6 months
Time frame: 3 months and 6 months after initiation of therapy
Change in serum sodium level
Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months after initiation of desmopressin therapy
Change in serum 25-hydroxyvitamin D level
Time frame: Baseline, 1 month, 3 months, and 6 months after initiation of therapy
Incidence of hyponatremia
Time frame: Baseline to 6 months after initiation of therapy
Incidence of headache
Time frame: Baseline to 6 months
Incidence of gastrointestinal symptoms
Time frame: Baseline to 6 months
Incidence of polyuria
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the study results may be shared with qualified researchers upon reasonable request. Shared data will include variables necessary to confirm the primary and secondary outcome analyses. No information that could identify participants will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and Desmopressin in people with Nocturnal Enuresis and Vitamin D Deficiency, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of wet nights per week at 3 months (time frame: Baseline and 3 months after initiation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.