Study on the Correlation Between Fat Soluble Vitamins and Non-alcoholic Fatty Liver Disease

NCT ID: NCT06512701

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-03
• Study Completion Date: 2026-07-10

Brief 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. 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.

Conditions

Non-Alcoholic Fatty Liver Disease; Fat Soluble Vitamin Deficiencies and Disorders

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

This study is an observational study without any intervention measures.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old, both male and female;

2. Voluntarily participate in this study and sign an informed consent form;

3. Diagnosed NAFLD through abdominal ultrasound;

Exclusion Criteria

1. 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;

2. Surgery was performed within 6 months, and blood donation, transfusion, or significant blood loss occurred within 4 months;

3. Have taken vitamin supplements within 2 weeks;

4. Women are in pregnancy, lactation, or within one year after childbirth;

5. Alcohol abuse (alcohol intake ≥ 140 g/week for males and ≥ 70 g/week for females)

6. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Liu Zhong

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhong Liu, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhong Liu, MD

Role: CONTACT

liuzhongzheyi@zju.edu.cn

+86 13957104885

Facility Contacts

Zhong Liu, MD

Role: primary

liuzhongzheyi@zju.edu.cn

+86 13957104885

Other Identifiers

20240727

Identifier Type: -

Identifier Source: org_study_id