Non-Alcoholic Fatty Liver DiseaseNCT06512701
Study on the Correlation Between Fat Soluble Vitamins and Non-alcoholic Fatty Liver Disease
An observational study of Non-Alcoholic Fatty Liver Disease and Fat Soluble Vitamin Deficiencies and Disorders, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Excessive or insufficient levels of vitamins in the body can affect health. With the prevalence of obesity and MetS, NAFLD has become the leading cause of chronic liver disease and abnormal liver biochemical indicators in health examinations in China. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Fat Soluble Vitamin Deficiencies and Disorders
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2024to 10 Jul 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18 and above who underwent physical examinations at the Health Management Center of the First Affiliated Hospital of Zhejiang University School of Medicine from July 2024 to June 2026.
Who may be able to join
- Age ≥ 18 years old, both male and female;
- Voluntarily participate in this study and sign an informed consent form;
- Diagnosed NAFLD through abdominal ultrasound;
Who cannot join
- Acute and chronic infections, severe cardiovascular and cerebrovascular diseases, respiratory system diseases, urinary system diseases, rheumatic diseases, tumors, and pituitary dysfunction; Or have hepatitis B, hepatitis C virus, or acquired immunodeficiency syndrome;
- Surgery was performed within 6 months, and blood donation, transfusion, or significant blood loss occurred within 4 months;
- Have taken vitamin supplements within 2 weeks;
- Women are in pregnancy, lactation, or within one year after childbirth;
- Alcohol abuse (alcohol intake ≥ 140 g/week for males and ≥ 70 g/week for females)
- The serum creatinine (SCr) exceeds twice the following abnormal values, with the standard of abnormal values being: male (20-59 years old)>97 μ mol/L, male (60-79 years old)>111 μ mol/L; Female (20-59 years old)>73 μ mol/L, female (60-79 years old)>81 μ mol/L.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
Zhong Liu, MD, +86 13957104885, liuzhongzheyi@zju.edu.cn
About this study
Excessive or insufficient levels of vitamins in the body can affect health. With the prevalence of obesity and MetS, NAFLD has become the leading cause of chronic liver disease and abnormal liver biochemical indicators in health examinations in China. The current research results on serum vitamin A, D, and E levels in NAFLD patients are controversial. Therefore, this study mainly explores the correlation between serum FSV levels and NAFLD, providing reference for nutrition and clinical management of NAFLD patients.
Read the detailed description
This is a single center cross-sectional study. In this study, 4000 eligible patients will be recruited and demographic information and clinical data of all study subjects will be collected. According to the results of abdominal ultrasound, the patients were divided into NAFLD group and non NAFLD group. The levels of fat soluble vitamins in the two groups were compared to explore the correlation between different concentrations of fat soluble vitamin levels and the risk of NAFLD.
- Keywords
- cross-sectional study, correlation, dose-response relationship
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
This study is an observational study without any intervention measures.
What is being measured
The primary outcome is the main question the study is designed to answer.
non-alcoholic fatty liver disease prevanlence
Measured: Day 1
serum vitamin A
Measured: Day 1
serum vitamin D
Measured: Day 1
serum vitamin E
Measured: Day 1
serum vitamin k
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start3 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhong, First Affiliated Hospital of Zhejiang University
- Investigators
- Zhong Liu, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512701
- Sponsor's protocol ID
- 20240727
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between Fat Soluble Vitamins and Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06512701
- Acronym / sponsor ID
- 20240727
- Keywords
- cross-sectional study, correlation, dose-response relationship
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 22 Jul 2024 (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.
Excessive or insufficient levels of vitamins in the body can affect health. With the prevalence of obesity and MetS, NAFLD has become the leading cause of chronic liver disease and abnormal liver biochemical indicators in health examinations in China. The current research results on serum vitamin A, D, and E levels in NAFLD patients are controversial. Therefore, this study mainly explores the correlation between serum FSV levels and NAFLD, providing reference for nutrition and clinical management of NAFLD patients.
Detailed description
This is a single center cross-sectional study. In this study, 4000 eligible patients will be recruited and demographic information and clinical data of all study subjects will be collected. According to the results of abdominal ultrasound, the patients were divided into NAFLD group and non NAFLD group. The levels of fat soluble vitamins in the two groups were compared to explore the correlation between different concentrations of fat soluble vitamin levels and the risk of NAFLD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 and above who underwent physical examinations at the Health Management Center of the First Affiliated Hospital of Zhejiang University School of Medicine from July 2024 to June 2026.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old, both male and female;
- Voluntarily participate in this study and sign an informed consent form;
- Diagnosed NAFLD through abdominal ultrasound;
Key exclusion criteria (6 listed)
- Acute and chronic infections, severe cardiovascular and cerebrovascular diseases, respiratory system diseases, urinary system diseases, rheumatic diseases, tumors, and pituitary dysfunction; Or have hepatitis B, hepatitis C virus, or acquired immunodeficiency syndrome;
- Surgery was performed within 6 months, and blood donation, transfusion, or significant blood loss occurred within 4 months;
- Have taken vitamin supplements within 2 weeks;
- Women are in pregnancy, lactation, or within one year after childbirth;
- Alcohol abuse (alcohol intake ≥ 140 g/week for males and ≥ 70 g/week for females)
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 |
|---|---|---|
| This study is an observational study without any intervention measures. | Other | – |
Primary outcome
non-alcoholic fatty liver disease prevanlence
Time frame: Day 1
serum vitamin A
Time frame: Day 1
serum vitamin D
Time frame: Day 1
serum vitamin E
Time frame: Day 1
serum vitamin k
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- 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.
Zhong Liu, MD principal investigator
First Affiliated Hospital of Zhejiang 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 Non-Alcoholic Fatty Liver Disease and Fat Soluble Vitamin Deficiencies and Disorders, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Liu, MD (+86 13957104885, liuzhongzheyi@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non-alcoholic fatty liver disease prevanlence (time frame: Day 1). The study lists 5 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 22 Jul 2024.