Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06512688

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-07-22

100000

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

H

Huizhou Municipal Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, male or female
  • Undergo a health examination at this hospital and maintain good physical health
  • Voluntarily agree to participate and sign informed consent
  • No acute or chronic infections or diseases including cardiovascular, cerebrovascular, diabetes, respiratory, urinary, thyroid, digestive, rheumatic, blood system diseases, tumors, pituitary dysfunction
  • No hepatitis B, hepatitis C virus, or acquired immunodeficiency syndrome
  • Blood pressure: systolic <140 mmHg and diastolic <90 mmHg
  • Body mass index (BMI) between 18.5 and less than 28 kg/m2
  • No surgery in the past 6 months, no blood donation, transfusion, or significant blood loss in past 4 months
  • No long-term medication use or vitamin supplements within 2 weeks
  • Women not pregnant, breastfeeding, or within one year after childbirth
  • No alcohol abuse (less than 140 g/week for males and less than 70 g/week for females) and smoking (less than 20 cigarettes/day)
Not Eligible

You will not qualify if you...

  • Elevated liver enzymes: ALT (male >50 U/L, female >40 U/L), GGT (male >60 U/L, female >45 U/L), AST (male >40 U/L, female >35 U/L), ALP (male >125 U/L, female >100 U/L)
  • Serum albumin below 40 g/L
  • Elevated serum creatinine above age and gender-specific limits
  • Fasting blood glucose 7.0 mmol/L or higher
  • Abnormal white blood cell count below 3.5 x 10^9/L or above 9.5 x 10^9/L
  • Low hemoglobin (male <120 g/L, female <110 g/L)
  • Glycated hemoglobin below 4% or above 6%
  • High total cholesterol (5.2 mmol/L or higher) or triglycerides (1.7 mmol/L or higher)
  • Elevated LDL cholesterol 3.4 mmol/L or higher or low HDL cholesterol below 1.0 mmol/L
  • Serum uric acid above 420 µmol/L

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

Z

Zhong Liu

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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