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

NCT06512701 | Recruiting

• 1 other identifier: 20240727
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cross-sectional study; correlation; dose-response relationship

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years old, both male and female;
• Voluntarily participate in this study and sign an informed consent form;
• Diagnosed NAFLD through abdominal ultrasound;

You may not qualify if:

• 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;
• Surgery was performed within 6 months, and blood donation, transfusion, or significant blood loss occurred within 4 months;
• Have taken vitamin supplements within 2 weeks;
• Women are in pregnancy, lactation, or within one year after childbirth;
• Alcohol abuse (alcohol intake ≥ 140 g/week for males and ≥ 70 g/week for females)
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhong Liu, MD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong Liu, MD

CONTACT

+86 13957104885; liuzhongzheyi@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 22, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)