Clinical trial NCT06512701: Study on the Correlation Between Fat Soluble Vitamins and Non-alcoholic Fatty Liver Disease
Official title: Study on the Correlation Between Fat Soluble Vitamins and Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Alcoholic Fatty Liver Disease
Fat Soluble Vitamin Deficiencies and Disorders
Keywords: cross-sectional study
correlation
dose-response relationship
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: non-alcoholic fatty liver disease prevanlence
timeFrame: Day 1
measure: serum vitamin A
timeFrame: Day 1
measure: serum vitamin D
timeFrame: Day 1
measure: serum vitamin E
timeFrame: Day 1
measure: serum vitamin k
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Zhong Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: