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RECRUITING

NCT06512688

Establishing Reference Ranges for Fat-Soluble Vitamins in Healthy Chinese Adults

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

Vitamins are essential micronutrients required for maintaining normal physiological functions and metabolism in humans. Among them, fat-soluble vitamins (FSV) such as vitamins A, D, E, and K are absorbed in the intestines in the presence of fat. Both deficiencies and excesses of these vitamins can affect health. Current global studies on FSVs in healthy populations are often limited to specific types or regions, and comprehensive data on all four FSVs in the healthy Chinese population are lacking. This study aims to fill this gap by collecting and analyzing FSV levels from healthy adults across multiple regions in China, establishing a reference range for clinical evaluation and early disease intervention.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100000

Start Date

2024-07-03

Completion Date

2026-08-02

Last Updated

2024-07-22

Healthy Volunteers

Yes

Conditions

Fat Soluble Vitamin Deficiencies and Disorders

Interventions

OTHER

Unknown

This is a cross-sectional study without intervention.

Inclusion Criteria: 1. Age ≥ 18 years old, both male and female; 2. Undergo a health examination in this hospital and consciously maintain good physical health; 3. Voluntarily participate in this study and sign an informed consent form; 4. No acute and chronic diseases: no acute and chronic infections, cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, urinary diseases, thyroid diseases, digestive diseases, rheumatic diseases, blood system diseases, tumors, pituitary dysfunction; No hepatitis B, hepatitis C virus, or acquired immunodeficiency syndrome; 5. Blood pressure: systolic blood pressure\<140 mmHg and diastolic blood pressure\<90 mmHg; 6. BMI (body mass index):\<28 kg/m2 and ≥ 18.5 kg/m2; 7. No surgery was performed within 6 months, no blood donation, transfusion, or significant blood loss occurred within 4 months; 8. No long-term medication history, no medication or vitamin supplements taken within 2 weeks; 9. Women who are not pregnant, breastfeeding, or within one year after childbirth; 10. No alcohol abuse (alcohol consumption but alcohol intake\<140 g/week for males and\<70 g/week for females), and smoking (\<20 cigarettes/day). Exclusion Criteria: 1. Serum alanine aminotransferase (ALT): Male\>50 U/L, female\>40 U/L; Or serum gamma glutamyltransferase (GGT): male\>60 U/L, female\>45 U/L; Or serum aspartate aminotransferase (AST): male\>40 U/L, female\>35 U/L; Or serum alkaline phosphatase (ALP): male\>125 U/L, female (20-49 years old)\>100 U/L, female (50-79 years old)\>100 U/L; 2. Serum albumin (ALB) \< 40 g/L; 3. Serum creatinine (SCr): 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; 4. Fasting blood glucose (FBG) ≥ 7.0 mmol/L; 5. White blood cell count (WBC): \< 3.5 × 109/L or \> 9.5 × 109/L; 6. Hemoglobin (Hb): Male \< 120 g/L; Female\<110 g/L; 7. Glycated hemoglobin (HbA1c)\<4% or\>6%; 8. Total cholesterol (TC) ≥ 5.2 mmol/L; Or triglycerides (TG) ≥ 1.7 mmol/L; 9. Low density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L; Or high-density lipoprotein cholesterol (HDL-C)\<1.0 mmol/L; 10. Serum uric acid (UA)\>420 μ mol/L.

Locations (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China