Vitamin D Serum Levels in Monosymptomatic Enuretic and Non Enuretic Children

Nocturnal Enuresis Clinical Trial

Official title:

A Comparative Study of Vitamin D Serum Levels in Monosymptomatic Enuretic Children and Non-enuretic Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06243042
• Other study ID #: ASU-7122021
• Status: Completed
• Start date: February 12, 2020
• Est. completion date: September 24, 2020

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 24, 2020
• Est. primary completion date: August 30, 2020
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Diagnostic Test:
• 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.
• 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.

Other:
• Frequency volume chart
volume and frequency from time of sleep till 8 am

Locations

Country	Name	City	State
Egypt	Cairo	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D level	low vitamin d levels in enuretic group	through study completion, average 1 year.
Secondary	nocturnal polyuria	frequency volume chart idobtained	through study completion, average 1 year.
Secondary	low nocturnal urine osmolality	nocturnal urine osmolality	through study completion, average 1 year.