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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease; Fat Soluble Vitamin Deficiencies and Disorders
• Intervention / Treatment: Other

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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Zhong Liu, MD; Phone Number: +86 13957104885; Email: liuzhongzheyi@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • First Affiliated Hospital of Zhejiang University
      • Contact: Zhong Liu, MD; Phone Number: +86 13957104885; Email: liuzhongzheyi@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
non-alcoholic fatty liver disease prevanlence	Day 1
serum vitamin A	Day 1
serum vitamin D	Day 1
serum vitamin E	Day 1
serum vitamin k	Day 1

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Zhong Liu, MD, First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 10, 2026

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: correlation; cross-sectional study; dose-response relationship
• Additional Relevant MeSH Terms: Digestive System Diseases; Nutrition Disorders; Deficiency Diseases; Malnutrition; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Avitaminosis
• Other Study ID Numbers: 20240727

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No