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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06512701

Enrollment

4000

Registered

2024-07-22

Start date

2024-07-03

Completion date

2026-07-10

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cross-sectional study, correlation, dose-response relationship

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactZhong Liu, MD

liuzhongzheyi@zju.edu.cn+86 13957104885

Outcome results