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

Recruiting

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

• Registration Number: NCT06512701
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-03
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serum vitamin A	Day 1
non-alcoholic fatty liver disease prevanlence	Day 1
serum vitamin k	Day 1
serum vitamin D	Day 1
serum vitamin E	Day 1

Trial Locations

Locations (1)

First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China