Vitamin D Serum Levels in Monosymptomatic Enuretic and Non Enuretic Children

NCT ID: NCT06243042

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-12

Study Completion Date

2020-09-24

Brief Summary

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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

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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

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Nocturnal Enuresis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Enuretic

Children complaining of monosymptomatic enuresis

serum vitamin D

Intervention Type DIAGNOSTIC_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 osmolality

Intervention Type DIAGNOSTIC_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 chart

Intervention Type OTHER

volume and frequency from time of sleep till 8 am

Non-enuretic

Healthy non enuretic children

serum vitamin D

Intervention Type DIAGNOSTIC_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 osmolality

Intervention Type DIAGNOSTIC_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 chart

Intervention Type OTHER

volume and frequency from time of sleep till 8 am

Interventions

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serum vitamin D

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.

Intervention Type DIAGNOSTIC_TEST

urine osmolality

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.

Intervention Type DIAGNOSTIC_TEST

Frequency volume chart

volume and frequency from time of sleep till 8 am

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Diaa Mostafa

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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diaa mostafa, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Cairo

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 39473396 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ASU-7122021

Identifier Type: -

Identifier Source: org_study_id

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