- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06827769
Serum Zinc and Serum Magnesium in Chronic Liver Disease Patients
Study of Serum Zinc and Magnesium as Trace Elements in Patients With Chronic Liver Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gharbyea
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Tanta, Gharbyea, Egypt, 31516
- Tanta University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chronic liver disease diagnosed by physical examination, laboratory investigations, and imaging study.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control
60 healthy subjects as control.
|
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 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. |
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
measuring serum zinc level in chronic liver disease patients
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
|
measuring serum magnesium level in chronic liver disease patients
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
correlation of serum zinc and magnesium with liver disease severity
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eman B Elsaadany, Pediatric medicine Department, Faculty of Medicine, Tanta University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36264PR580/2/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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