Status:
RECRUITING
Establishing Reference Ranges for Fat-Soluble Vitamins in Healthy Chinese Adults
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
Huizhou Municipal Central Hospital
Affiliated Hospital of Jiaxing University
Conditions:
Fat Soluble Vitamin Deficiencies and Disorders
Eligibility:
All Genders
18+ years
Brief 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 absor...
Detailed Description
Vitamins are crucial organic micronutrients necessary for maintaining human physiological functions and metabolic processes. They are typically categorized into water-soluble vitamins and fat-soluble ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 3 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 2 2026
Estimated Enrollment :
100000 Patients enrolled
Trial Details
Trial ID
NCT06512688
Start Date
July 3 2024
End Date
August 2 2026
Last Update
July 22 2024
Active Locations (1)
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1
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003