NCT06827769

Brief Summary

The goal of this observational cross-sectional study is to assess the relationship between serum levels of magnesium and zinc in pediatric and adult patients with chronic liver disease and the clinic-laboratory variables. Researchers will compare serum levels of zinc and magnesium in patients with chronic liver disease and healthy controls. Assess the correlation between serum zinc and magnesium and the presence and severity of chronic liver disease and cirrhosis. Participants will be subjected to history taking, clinical examination, laboratory investigations, and abdominal ultrasonography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

February 4, 2025

Last Update Submit

February 13, 2025

Conditions

Keywords

serum zinc,serum magnesiumchronic liver diseasecirhosistrace elements

Outcome Measures

Primary Outcomes (2)

  • measuring serum zinc level in chronic liver disease patients

    through study completion, an average of 1 year

  • measuring serum magnesium level in chronic liver disease patients

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • correlation of serum zinc and magnesium with liver disease severity

    through study completion, an average of 1 year

Study Arms (2)

Control

60 healthy subjects as control.

Diagnostic Test: serum zinc and magnesium

Chronic liver disease

80 patients with chronic liver disease diagnosed by physical examination, laboratory investigations, and imaging study. This group will be subdivided into non-cirrhotic and cirrhotic liver groups.

Diagnostic Test: serum zinc and magnesium

Interventions

participants will be subjected to laboratory investigations (complete blood picture, liver and kidney function tests, Prothrombin time, international normalized ratio (INR), serum zinc, and magnesium).

Chronic liver diseaseControl

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects from the outpatient clinic and inpatient of the Tropical Medicine and Infectious Diseases Department and Pediatric Department at Tanta University Hospitals

You may qualify if:

  • Chronic liver disease diagnosed by physical examination, laboratory investigations, and imaging study.

You may not qualify if:

  • Patients with Wilson disease.
  • Patients with chronic renal diseases.
  • Patients with IBD or any other cause of chronic diarrhea.
  • Drugs affecting levels of trace elements e.g. corticosteroids, digoxin thiazide, diuretics, and supplements 30 days before study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eman B Elsaadany

    Pediatric medicine Department, Faculty of Medicine, Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical medicine

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 14, 2025

Study Start

March 1, 2024

Primary Completion

January 30, 2025

Study Completion

February 1, 2025

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations