Chronic Liver Disease and CirrhosisNCT06827769
Serum Zinc and Serum Magnesium in Chronic Liver Disease Patients
An observational study of Chronic Liver Disease and Cirrhosis, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis
- What is being tested?
- serum zinc and magnesium
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: subjects from the outpatient clinic and inpatient of the Tropical Medicine and Infectious Diseases Department and Pediatric Department at Tanta University Hospitals
Who may be able to join
- Chronic liver disease diagnosed by physical examination, laboratory investigations, and imaging study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Liver Disease and Cirrhosis
- Being tested
- serum zinc and magnesium
- Keywords
- serum zinc,, serum magnesium, chronic liver disease, cirhosis, trace elements
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum zinc and magnesiumDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | 60 healthy subjects as control. Receives: 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. Receives: Diagnostic Test: serum zinc and magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring serum zinc level in chronic liver disease patients
Measured: through study completion, an average of 1 year
measuring serum magnesium level in chronic liver disease patients
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
correlation of serum zinc and magnesium with liver disease severity
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Mar 2024
- Primary completion30 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease and CirrhosisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mamdouh Elkafoury, Tanta University
- Investigators
- Eman B Elsaadany, Principal investigator, Pediatric medicine Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827769
- Sponsor's protocol ID
- 36264PR580/2/24
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Serum Zinc and Magnesium as Trace Elements in Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT06827769
- Acronym / sponsor ID
- 36264PR580/2/24
- Conditions
- Chronic Liver Disease and Cirrhosis
- Keywords
- serum zinc,, serum magnesium, chronic liver disease, cirhosis, trace elements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: serum zinc and magnesium60 healthy subjects as control. |
| Chronic liver disease | – | Diagnostic Test: serum zinc and magnesium80 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjects from the outpatient clinic and inpatient of the Tropical Medicine and Infectious Diseases Department and Pediatric Department at Tanta University Hospitals
Key inclusion criteria (1 listed)
- Chronic liver disease diagnosed by physical examination, laboratory investigations, and imaging study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum zinc and magnesiumparticipants will be subjected to laboratory investigations (complete blood picture, liver and kidney function tests, Prothrombin time, international normalized ratio (INR), serum zinc, and magnesium). | Diagnostic test | Chronic liver disease, Control |
Primary outcome
measuring serum zinc level in chronic liver disease patients
Time frame: 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
1 secondary outcome
correlation of serum zinc and magnesium with liver disease severity
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman B Elsaadany principal investigator
Pediatric medicine Department, Faculty of Medicine, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease and Cirrhosis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring serum zinc level in chronic liver disease patients (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.