Nocturnal EnuresisNCT06243042
Vitamin D Serum Levels in Monosymptomatic Enuretic and Non Enuretic Children
An observational study of Nocturnal Enuresis, run by Ain Shams University at 1 site in Egypt.
Trial summary
We are group of researchers interested in causes and management of nocturnal enuresis, we embarked on this research on 2020 and we reached promising results regarding the role of vitamin D serum level in etiology and management of monosymptomatic enuresis. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- serum vitamin D, urine osmolality and Frequency volume chart
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2020to 24 Sep 2020
- Phase
- Observational
- 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 5 to 15 years
- All sexes
- Child
Study population: male and female children from 5-15 years wer selcted in two groups 60 enuretic children 60 non enuretic children as a control group
Who may be able to join
- Patients with PMNE.
- which was defined as bedwetting frequency of 3 or more nights per week for at least 2 weeks of observation.
- Didn't receive any previous treatment for enuresis.
Who cannot join
- Patients with non-monosymptomatic enuresis (associated with storage and/or voiding symptoms). -Patients with anatomical abnormalities (Meatal stenosis, Hypospadias, Epispadias, etc.).
- Patients with neurological diseases.
- Patients with Renal impairment.
- Patient with previous pelvic, urological or brain and spinal cord surgery.
- Patients with chronic constipation and irritable bowel habits.
- Patients with active urinary tract infection.
- Patients who are on vitamin D supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Vitamin D Serum Levels in Monosymptomatic Enuretic Children and Non-enuretic Children
We are group of researchers interested in causes and management of nocturnal enuresis, we embarked on this research on 2020 and we reached promising results regarding the role of vitamin D serum level in etiology and management of monosymptomatic enuresis.
Read the detailed description
this research was conducted as a comparative study regarding serum vitamin D levels in monosymptomatic enuretic and non enuretic children, also we compared urine osmolality and nocturnal polyuria in both groups and we found that low vitamin D levels are correlated with low nocturnal urine osmolality and increased incidence of nocturnal polyuria
- Conditions
- Nocturnal Enuresis
- Being tested
- serum vitamin D, urine osmolality, Frequency volume chart
- Keywords
- Nocturnal enuresis, Vitamin D
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum vitamin DDiagnostic test
blood sample for serum vitamin D level Vitamin D serum level was measures using the ELISA technique. The Cal Biotech Vitamin D Kit (Mannheim, Germany) was used, which is a solid phase enzyme linked immunoassay (ELISA), based on the principal of competitive binding. Vitamin D deficiency was defined as serum Vit. D below 20 ng/ml.
urine osmolalityDiagnostic test
nocturnal urine osmolality: Clear instructions for mothers were to let the child void before sleep and every two hours till 8 am. Short intervals were meant to avoid enuretic episodes during calculation of nocturnal urine volume, and if occurred it mandates the repeat of chart on another day.
Nocturnal urine collected over the night was tested for osmolality, it was measured in mOsm/kg.
Frequency volume chartOther
volume and frequency from time of sleep till 8 am
| Study group | Role | What they receive |
|---|---|---|
| Enuretic | Children complaining of monosymptomatic enuresis Receives: Diagnostic Test: serum vitamin D; Diagnostic Test: urine osmolality; Other: Frequency volume chart | |
| Non-enuretic | Healthy non enuretic children Receives: Diagnostic Test: serum vitamin D; Diagnostic Test: urine osmolality; Other: Frequency volume chart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level
low vitamin d levels in enuretic group
Measured: through study completion, average 1 year.
Secondary outcomes (2)
nocturnal polyuria
frequency volume chart idobtained
Measured: through study completion, average 1 year.
low nocturnal urine osmolality
nocturnal urine osmolality
Measured: through study completion, average 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start12 Feb 2020
- Primary completion30 Aug 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa Mostafa, Ain Shams University
- Investigators
- diaa mostafa, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243042
- Sponsor's protocol ID
- ASU-7122021
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mostafa D, Shaker H, Badr A, Abuelnaga M. A Comparative Study of Vitamin D Serum Levels in Monosymptomatic Enuretic Children and Non-Enuretic Children. Neurourol Urodyn. 2025 Jan;44(1):212-219. doi: 10.1002/nau.25618. Epub 2024 Oct 30.
PubMed 39473396
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Vitamin D Serum Levels in Monosymptomatic Enuretic Children and Non-enuretic Children
- ClinicalTrials.gov ID
- NCT06243042
- Acronym / sponsor ID
- ASU-7122021
- Conditions
- Nocturnal Enuresis
- Keywords
- Nocturnal enuresis, Vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 6 Feb 2024 (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.
We are group of researchers interested in causes and management of nocturnal enuresis, we embarked on this research on 2020 and we reached promising results regarding the role of vitamin D serum level in etiology and management of monosymptomatic enuresis.
Detailed description
this research was conducted as a comparative study regarding serum vitamin D levels in monosymptomatic enuretic and non enuretic children, also we compared urine osmolality and nocturnal polyuria in both groups and we found that low vitamin D levels are correlated with low nocturnal urine osmolality and increased incidence of nocturnal polyuria
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enuretic | – | Diagnostic Test: serum vitamin D, Diagnostic Test: urine osmolality, Other: Frequency volume chartChildren complaining of monosymptomatic enuresis |
| Non-enuretic | – | Diagnostic Test: serum vitamin D, Diagnostic Test: urine osmolality, Other: Frequency volume chartHealthy non enuretic children |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- male and female children from 5-15 years wer selcted in two groups 60 enuretic children 60 non enuretic children as a control group
Key inclusion criteria (3 listed)
- Patients with PMNE.
- which was defined as bedwetting frequency of 3 or more nights per week for at least 2 weeks of observation.
- Didn't receive any previous treatment for enuresis.
Key exclusion criteria (7 listed)
- Patients with non-monosymptomatic enuresis (associated with storage and/or voiding symptoms). -Patients with anatomical abnormalities (Meatal stenosis, Hypospadias, Epispadias, etc.).
- Patients with neurological diseases.
- Patients with Renal impairment.
- Patient with previous pelvic, urological or brain and spinal cord surgery.
- Patients with chronic constipation and irritable bowel habits.
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 |
|---|---|---|
| serum vitamin Dblood sample for serum vitamin D level Vitamin D serum level was measures using the ELISA technique. The Cal Biotech Vitamin D Kit (Mannheim, Germany) was used, which is a solid phase enzyme linked immunoassay (ELISA), based on the principal of competitive binding. Vitamin D deficiency was defined as serum Vit. D below 20 ng/ml. | Diagnostic test | Enuretic, Non-enuretic |
| urine osmolalitynocturnal urine osmolality: Clear instructions for mothers were to let the child void before sleep and every two hours till 8 am. Short intervals were meant to avoid enuretic episodes during calculation of nocturnal urine volume, and if occurred it mandates the repeat of chart on another day. Nocturnal urine collected over the night was tested for osmolality, it was measured in mOsm/kg. | Diagnostic test | Enuretic, Non-enuretic |
| Frequency volume chartvolume and frequency from time of sleep till 8 am | Other | Enuretic, Non-enuretic |
Primary outcome
Vitamin D level
Time frame: through study completion, average 1 year.
low vitamin d levels in enuretic group
2 secondary outcomes
nocturnal polyuria
Time frame: through study completion, average 1 year.
low nocturnal urine osmolality
Time frame: through study completion, average 1 year.
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 6 Feb 2024.
- Derived from this study: PubMed 39473396Mostafa D, Shaker H, Badr A, Abuelnaga M. A Comparative Study of Vitamin D Serum Levels in Monosymptomatic Enuretic Children and Non-Enuretic Children. Neurourol Urodyn. 2025 Jan;44(1):212-219. doi: 10.1002/nau.25618. Epub 2024 Oct 30.
- Individual participant dataSharing planned: No
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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.
diaa mostafa, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturnal Enuresis, 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 3 inclusion and 7 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 6 Feb 2024. 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?
Vitamin D level (time frame: through study completion, average 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243042, which also lists 1 linked publication.
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 6 Feb 2024.