RecruitingNCT06512688

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


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

100,000 participants

Start Date

Jul 3, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • Age ≥ 18 years old, both male and female;
  • Undergo a health examination in this hospital and consciously maintain good physical health;
  • Voluntarily participate in this study and sign an informed consent form;
  • 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;
  • Blood pressure: systolic blood pressure<140 mmHg and diastolic blood pressure<90 mmHg;
  • BMI (body mass index):<28 kg/m2 and ≥ 18.5 kg/m2;
  • No surgery was performed within 6 months, no blood donation, transfusion, or significant blood loss occurred within 4 months;
  • No long-term medication history, no medication or vitamin supplements taken within 2 weeks;
  • Women who are not pregnant, breastfeeding, or within one year after childbirth;
  • 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 Criteria10

  • 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;
  • Serum albumin (ALB) < 40 g/L;
  • 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;
  • Fasting blood glucose (FBG) ≥ 7.0 mmol/L;
  • White blood cell count (WBC): < 3.5 × 109/L or > 9.5 × 109/L;
  • Hemoglobin (Hb): Male < 120 g/L; Female<110 g/L;
  • Glycated hemoglobin (HbA1c)<4% or>6%;
  • Total cholesterol (TC) ≥ 5.2 mmol/L; Or triglycerides (TG) ≥ 1.7 mmol/L;
  • Low density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L; Or high-density lipoprotein cholesterol (HDL-C)<1.0 mmol/L;
  • Serum uric acid (UA)>420 μ mol/L.

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Interventions

OTHER

This is a cross-sectional study without intervention.


Locations(1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

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NCT06512688


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