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NCT Number: NCT06512701

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

Zhong Liu, MD

CONTACT

[email protected]

+86 13957104885

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. non-alcoholic fatty liver disease prevanlence

    Time frame: Day 1

  2. serum vitamin A

    Time frame: Day 1

  3. serum vitamin D

    Time frame: Day 1

  4. serum vitamin E

    Time frame: Day 1

  5. serum vitamin k

    Time frame: Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Zhong Liu, MD

CONTACT

[email protected]

+86 13957104885

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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