NAFLDNAFLDNCT04834063
Serum Selenium and Zinc Levels in Non-alcoholic Fatty Liver Disease Patients
An observational study of NAFLD, run by Sohag University at 1 site in Egypt.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) includes a wide range of disorders that consist of simple fatty infiltration, steatohepatitis (NASH), and end-stage liver disease (cirrhosis). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD
- What is being tested?
- Serum Zinc a level, serum selenium level and Fibroscan measurement
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2021to 25 Sep 2021
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: group (1): patients diagnosed to have NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021. Group (2): a control group of 30 healthy volunteers who looks normal on ultrasonographic examination
Who may be able to join
- patients diagnosed to have NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021.
Who cannot join
- Any patient with a chronic liver disease rather than NAFLD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Serum Selenium and Zinc Levels in Non-alcoholic Fatty Liver Disease Patients
Non-alcoholic fatty liver disease (NAFLD) includes a wide range of disorders that consist of simple fatty infiltration, steatohepatitis (NASH), and end-stage liver disease (cirrhosis). NAFLD is the most common cause of chronic liver disease worldwide and increases the risk of end-stage liver disease and hepatocellular carcinoma (HCC) . While risk factors such as obesity, diabetes, and a sedentary lifestyle may increase the risk of NAFLD, studies have shown that environmental exposures may further contribute to the pathogenesis of NAFLD. Although the pathogenic role of macronutrients is well established in both NAFLD and obesity, the contribution of micronutrients to NAFLD pathogenesis has garnered less attention than with obesity.
Selenium is an essential element in many biological functions and is an important component of human nutrition. Exposure to selenium can be found in nature, such as rocks and sediment, air, soil, fuel oil, drinking water and nutritional supplementation. It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation, DNA synthesis, reproduction, muscle function, and thyroid metabolism. Selenium concentrations have been studied in many diseases and organ systems including the liver. However, the exact relationship between selenium in patients with NAFLD is unclear.
Read more
Selenium is an essential element in many biological functions and is an important component of human nutrition. It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation, DNA synthesis, reproduction, muscle function, and thyroid metabolism. Selenium concentrations have been studied in many diseases and organ systems including the liver. However, the exact relationship between selenium in patients with NAFLD is unclear.
Despite data suggesting mineral deficiencies in NAFLD patients, most data do not support insufficient mineral consumption as a possible mechanism for these deficiencies, except in the case of zinc deficiency. Zinc is the second most prevalent trace element in the body. It is integrally involved in the normal life cycle and has many important regulatory, catalytic, and defensive functions. Zinc deficiency occurs in many types of liver disease, especially more advanced/decompensated disease.
Read the detailed description
We aim firstly to assess the serum selenium and zinc level in NAFLD patients, secondly to detect the association between hepatic fibrosis, steatosis, and serum selenium level in NAFLD patients, thirdly to detect if there is a synergistic effect of both molecules.
Patients and methods
Study design:
Case-control study.
Studied population \& locality:
This study will be conducted on two groups: Group (1): include 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021.
Group (2): a control group of 30 healthy volunteers who looks normal on ultrasonographic examination.
Exclusion criteria:
Any patient with a chronic liver disease rather than NAFLD.
Methods:
All included patients will be subjected to:
- Detailed history, complete general and systemic examination.
- BMI will be calculated as follow
- Abdominal Ultrasonography.
- Laboratory investigations:
- Fasting blood sugar
- Serum lipogram.
- Liver function tests.
- CBC.
- Estimation of serum selenium and zinc level.
- Liver stiffness measurements to detect the degree of fibrosis and measurement of the degree of steatosis using (Fibroscan).
Ethical considerations:
The study will be approved by The Ethical committee of medical research, Sohag Faculty of Medicine, Sohag University.
After an explanation about the nature of the procedures, possible complications, benefits, and steps of the study, all patients and controls will give written informed consent for participating in the study, performing the abdominal ultrasound, taking blood samples, performing fibroscan.
Statistical analysis:
Data will be analyzed using STATA version 12.1. Quantitative data were represented as mean, standard deviation, median, and range. Data will be analyzed using a student t-test to compare the means of the two groups. Qualitative data will be presented as numbers and percentages and will be compared using either the Chi-square test or Fisher exact test. P-value will be considered significant if it was less than 0.05.
- Conditions
- NAFLD
- Being tested
- Serum Zinc a level, serum selenium level, Fibroscan measurement
- Keywords
- NAFLD, Fibrosis, selenium, zinc
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Zinc a levelDiagnostic test
Diagnostic test
serum selenium levelDiagnostic test
Diagnostic test
Fibroscan measurementDiagnostic test
Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| NAFLD Cases | Non- alcoholic fatty liver disease Receives: Diagnostic Test: Serum Zinc a level; Diagnostic Test: serum selenium level; Diagnostic Test: Fibroscan measurement | |
| control | healthy individual with normal liver on abdominal ultrasound Receives: Diagnostic Test: Serum Zinc a level; Diagnostic Test: serum selenium level; Diagnostic Test: Fibroscan measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum selenium level in NAFLD patients
Measured: during the period from March 2021 to August 2021
the association between hepatic fibrosis and serum selenium level in NAFLD patients
Measured: during the period from March 2021 to August 2021
serum zinc level in NAFLD patients
Measured: during the period from March 2021 to August 2021
the association between hepatic fibrosis and serum zinc level in NAFLD patients
Measured: during the period from March 2021 to August 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start15 Mar 2021
- Primary completion5 Sep 2021
- Study completion25 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohammed Abdelrhman, Sohag University
- Investigators
- Radwa Farag, MD, Study chair, Sohag UniversityYasser Amin, MD, Study chair, Sohag UniversityHaitham Attia, MD, Study chair, Sohag UniversityAhmed Abdallah, MD, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834063
- Sponsor's protocol ID
- Soh-Med-21-03-12
- Acronym
- NAFLD
- Status last verified
- Nov 2021
- First submitted
- 30 Mar 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kosari F, Jamali R, Ramim T, Mosavi Jahan Abad E. The Correlation between Serum Zinc Level and Liver Histology in Non-Alcoholic Steatohepatitis. Iran J Pathol. 2019 Winter;14(1):17-25. doi: 10.30699/IJP.14.1.17. Epub 2018 Dec 27.
PubMed 31531097Reja M, Makar M, Visaria A, Marino D, Rustgi V. Increased serum selenium levels are associated with reduced risk of advanced liver fibrosis and all-cause mortality in NAFLD patients: National Health and Nutrition Examination Survey (NHANES) III. Ann Hepatol. 2020 Nov-Dec;19(6):635-640. doi: 10.1016/j.aohep.2020.07.006. Epub 2020 Jul 31.
PubMed 32745632Aigner E, Strasser M, Haufe H, Sonnweber T, Hohla F, Stadlmayr A, Solioz M, Tilg H, Patsch W, Weiss G, Stickel F, Datz C. A role for low hepatic copper concentrations in nonalcoholic Fatty liver disease. Am J Gastroenterol. 2010 Sep;105(9):1978-85. doi: 10.1038/ajg.2010.170. Epub 2010 Apr 20.
PubMed 20407430Pickett-Blakely O, Young K, Carr RM. Micronutrients in Nonalcoholic Fatty Liver Disease Pathogenesis. Cell Mol Gastroenterol Hepatol. 2018 Aug 23;6(4):451-462. doi: 10.1016/j.jcmgh.2018.07.004. eCollection 2018.
PubMed 30294653Mohammad MK, Zhou Z, Cave M, Barve A, McClain CJ. Zinc and liver disease. Nutr Clin Pract. 2012 Feb;27(1):8-20. doi: 10.1177/0884533611433534.
PubMed 22307488
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Selenium and Zinc Levels in Non-alcoholic Fatty Liver Disease Patients
- ClinicalTrials.gov ID
- NCT04834063
- Acronym / sponsor ID
- NAFLD / Soh-Med-21-03-12
- Conditions
- NAFLD
- Keywords
- NAFLD, Fibrosis, selenium, zinc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 6 Apr 2021 (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.
Non-alcoholic fatty liver disease (NAFLD) includes a wide range of disorders that consist of simple fatty infiltration, steatohepatitis (NASH), and end-stage liver disease (cirrhosis). NAFLD is the most common cause of chronic liver disease worldwide and increases the risk of end-stage liver disease and hepatocellular carcinoma (HCC) . While risk factors such as obesity, diabetes, and a sedentary lifestyle may increase the risk of NAFLD, studies have shown that environmental exposures may further contribute to the pathogenesis of NAFLD. Although the pathogenic role of macronutrients is well established in both NAFLD and obesity, the contribution of micronutrients to NAFLD pathogenesis has garnered less attention than with obesity.
Selenium is an essential element in many biological functions and is an important component of human nutrition. Exposure to selenium can be found in nature, such as rocks and sediment, air, soil, fuel oil, drinking water and nutritional supplementation. It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation, DNA synthesis, reproduction, muscle function, and thyroid metabolism. Selenium concentrations have been studied in many diseases and organ systems including the liver. However, the exact relationship between selenium in patients with NAFLD is unclear.
Selenium is an essential element in many biological functions and is an important component of human nutrition. It is a major component of many enzymes such as glutathione peroxidase and plays an important role in anti-oxidation, DNA synthesis, reproduction, muscle function, and thyroid metabolism. Selenium concentrations have been studied in many diseases and organ systems including the liver. However, the exact relationship between selenium in patients with NAFLD is unclear.
Despite data suggesting mineral deficiencies in NAFLD patients, most data do not support insufficient mineral consumption as a possible mechanism for these deficiencies, except in the case of zinc deficiency. Zinc is the second most prevalent trace element in the body. It is integrally involved in the normal life cycle and has many important regulatory, catalytic, and defensive functions. Zinc deficiency occurs in many types of liver disease, especially more advanced/decompensated disease.
Detailed description
We aim firstly to assess the serum selenium and zinc level in NAFLD patients, secondly to detect the association between hepatic fibrosis, steatosis, and serum selenium level in NAFLD patients, thirdly to detect if there is a synergistic effect of both molecules.
Patients and methods
Study design:
Case-control study.
Studied population \& locality:
This study will be conducted on two groups: Group (1): include 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021.
Group (2): a control group of 30 healthy volunteers who looks normal on ultrasonographic examination.
Exclusion criteria:
Any patient with a chronic liver disease rather than NAFLD.
Methods:
All included patients will be subjected to:
- Detailed history, complete general and systemic examination.
- BMI will be calculated as follow
- Abdominal Ultrasonography.
- Laboratory investigations:
- Fasting blood sugar
- Serum lipogram.
- Liver function tests.
- CBC.
- Estimation of serum selenium and zinc level.
- Liver stiffness measurements to detect the degree of fibrosis and measurement of the degree of steatosis using (Fibroscan).
Ethical considerations:
The study will be approved by The Ethical committee of medical research, Sohag Faculty of Medicine, Sohag University.
After an explanation about the nature of the procedures, possible complications, benefits, and steps of the study, all patients and controls will give written informed consent for participating in the study, performing the abdominal ultrasound, taking blood samples, performing fibroscan.
Statistical analysis:
Data will be analyzed using STATA version 12.1. Quantitative data were represented as mean, standard deviation, median, and range. Data will be analyzed using a student t-test to compare the means of the two groups. Qualitative data will be presented as numbers and percentages and will be compared using either the Chi-square test or Fisher exact test. P-value will be considered significant if it was less than 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD Cases | – | Diagnostic Test: Serum Zinc a level, Diagnostic Test: serum selenium level, Diagnostic Test: Fibroscan measurementNon- alcoholic fatty liver disease |
| control | – | Diagnostic Test: Serum Zinc a level, Diagnostic Test: serum selenium level, Diagnostic Test: Fibroscan measurementhealthy individual with normal liver on abdominal ultrasound |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- group (1): patients diagnosed to have NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021. Group (2): a control group of 30 healthy volunteers who looks normal on ultrasonographic examination
Key inclusion criteria (1 listed)
- patients diagnosed to have NAFLD by ultrasonography presented to the outpatient clinic of Tropical medicine and gastroenterology department, Sohag University Hospitals during the period from March 2021 to August 2021.
Key exclusion criteria (1 listed)
- Any patient with a chronic liver disease rather than NAFLD
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 a levelDiagnostic test | Diagnostic test | NAFLD Cases, control |
| serum selenium levelDiagnostic test | Diagnostic test | NAFLD Cases, control |
| Fibroscan measurementDiagnostic test | Diagnostic test | NAFLD Cases, control |
Primary outcome
serum selenium level in NAFLD patients
Time frame: during the period from March 2021 to August 2021
the association between hepatic fibrosis and serum selenium level in NAFLD patients
Time frame: during the period from March 2021 to August 2021
serum zinc level in NAFLD patients
Time frame: during the period from March 2021 to August 2021
the association between hepatic fibrosis and serum zinc level in NAFLD patients
Time frame: during the period from March 2021 to August 2021
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 2 Nov 2021.
- Background: PubMed 31531097Kosari F, Jamali R, Ramim T, Mosavi Jahan Abad E. The Correlation between Serum Zinc Level and Liver Histology in Non-Alcoholic Steatohepatitis. Iran J Pathol. 2019 Winter;14(1):17-25. doi: 10.30699/IJP.14.1.17. Epub 2018 Dec 27.
- Background: PubMed 32745632Reja M, Makar M, Visaria A, Marino D, Rustgi V. Increased serum selenium levels are associated with reduced risk of advanced liver fibrosis and all-cause mortality in NAFLD patients: National Health and Nutrition Examination Survey (NHANES) III. Ann Hepatol. 2020 Nov-Dec;19(6):635-640. doi: 10.1016/j.aohep.2020.07.006. Epub 2020 Jul 31.
- Background: PubMed 20407430Aigner E, Strasser M, Haufe H, Sonnweber T, Hohla F, Stadlmayr A, Solioz M, Tilg H, Patsch W, Weiss G, Stickel F, Datz C. A role for low hepatic copper concentrations in nonalcoholic Fatty liver disease. Am J Gastroenterol. 2010 Sep;105(9):1978-85. doi: 10.1038/ajg.2010.170. Epub 2010 Apr 20.
- Background: PubMed 30294653Pickett-Blakely O, Young K, Carr RM. Micronutrients in Nonalcoholic Fatty Liver Disease Pathogenesis. Cell Mol Gastroenterol Hepatol. 2018 Aug 23;6(4):451-462. doi: 10.1016/j.jcmgh.2018.07.004. eCollection 2018.
- Background: PubMed 22307488Mohammad MK, Zhou Z, Cave M, Barve A, McClain CJ. Zinc and liver disease. Nutr Clin Pract. 2012 Feb;27(1):8-20. doi: 10.1177/0884533611433534.
- 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.
Radwa Farag, MD study chair
Sohag University
Yasser Amin, MD study chair
Sohag University
Haitham Attia, MD study chair
Sohag 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 NAFLD, run by Sohag 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 1 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 2 Nov 2021. 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?
serum selenium level in NAFLD patients (time frame: during the period from March 2021 to August 2021). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834063, which also lists 5 linked publications.
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 2 Nov 2021.