Clinical trial NCT06827769: Serum Zinc and Serum Magnesium in Chronic Liver Disease Patients
Official title: Study of Serum Zinc and Magnesium as Trace Elements in Patients With Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Liver Disease and Cirrhosis
Keywords: serum zinc,
serum magnesium
chronic liver disease
cirhosis
trace elements
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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

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.

Detailed description: The progressive deterioration of liver tissue over time is a hallmark of chronic liver disorders (CLD). Liver diseases are linked to a number of risk factors, including environmental pollutants, genetics, and infectious diseases. The process of liver damage may be accelerated when multiple factors work together.

Due to their involvement in numerous metabolic pathways, trace elements are essential for preserving health. The liver plays a crucial role in controlling the metabolic pathway and transport, tissue distribution, toxicity, and trace element bioavailability. Certain metabolic illnesses are brought on by an excess or a shortage of certain trace elements, such as copper (Cu), magnesium (Mg), and zinc (Zn).

Zinc is necessary for DNA synthesis, RNA transcription, cell growth, protein synthesis, and regeneration. It also serves as a center of activity or cofactor for hundreds of enzymes (5). Numerous symptoms, such as anemia, dermatitis, stomatitis, alopecia, bedsores, decreased appetite, stunted growth, gonadal dysfunction, infection susceptibility, and taste problems, are brought on by zinc deficiency. Reduced albumin synthesis, low oral intake, increased urine excretion of zinc linked to portosystemic shunt, and impaired intestinal absorption are the causes of zinc insufficiency in CLD patients.

Magnesium is the fourth most abundant cation and the most prevalent intracellular ion. It has been connected to more than 300 enzymatic processes, including the cytolysis of antibodies, the synthesis of immunoglobin, and the adherence of resistant cells. Conversely, low magnesium levels in serum and liver tissue can slow the development of these conditions by interfering with mitochondrial activity, triggering inflammatory reactions, or causing metabolic anomalies.

This study aims to measure serum levels of zinc and magnesium in patients with chronic liver disease and to evaluate their correlation with clinic-laboratory variables.

This observational cross-sectional study will be performed on 80 subjects from the outpatient clinic and inpatient of the Tropical Medicine and Infectious Diseases Department and Pediatric Department at Tanta University Hospitals.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: measuring serum zinc level in chronic liver disease patients
timeFrame: through study completion, an average of 1 year
measure: measuring serum magnesium level in chronic liver disease patients
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: correlation of serum zinc and magnesium with liver disease severity
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbyea
Study officials:
affiliation: Pediatric medicine Department, Faculty of Medicine, Tanta University
name: Eman B Elsaadany
role: PRINCIPAL_INVESTIGATOR
References: