Vitamin D Serum Levels in Monosymptomatic Enuretic and Non Enuretic Children

NCT06243042 | Completed

• 1 other identifier: ASU-7122021
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nocturnal Enuresis

Keywords

Nocturnal enuresis; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Vitamin D level

  low vitamin d levels in enuretic group

  through study completion, average 1 year.

Secondary Outcomes (2)

• nocturnal polyuria

  through study completion, average 1 year.

• low nocturnal urine osmolality

  through study completion, average 1 year.

Study Arms (2)

Enuretic

Children complaining of monosymptomatic enuresis

Diagnostic Test: serum vitamin D; Diagnostic Test: urine osmolality; Other: Frequency volume chart

Non-enuretic

Healthy non enuretic children

Diagnostic Test: serum vitamin D; Diagnostic Test: urine osmolality; Other: Frequency volume chart

Interventions

serum vitamin D 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.

Enuretic; Non-enuretic

urine osmolality 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.

Enuretic; Non-enuretic

Frequency volume chart OTHER

volume and frequency from time of sleep till 8 am

Enuretic; Non-enuretic

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Cairo

Cairo, 11373, Egypt

Location

Related Publications (1)

• 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.

  PMID: 39473396 DERIVED

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• diaa mostafa, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 6, 2024
• Study Start: February 12, 2020
• Primary Completion: August 30, 2020
• Study Completion: September 24, 2020
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)