Establishing reference ranges for fat-soluble vitamins in healthy Chinese adults
This study is trying to find out the normal levels of vitamins A, D, E, and K in healthy adults in China to help doctors better understand vitamin deficiencies and excesses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06512688 on ClinicalTrials.gov |
What this trial studies
This study aims to collect and analyze levels of fat-soluble vitamins A, D, E, and K from healthy adults across multiple regions in China. By employing a multicenter approach, the research seeks to establish a comprehensive reference range for these vitamins in the Chinese population. This data will help in the clinical evaluation and early intervention of vitamin deficiencies and excesses. The study addresses the current lack of extensive data on fat-soluble vitamins in healthy individuals in China.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 and older without any acute or chronic diseases.
Not a fit: Patients with existing health conditions or those taking medications or supplements that could affect vitamin levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical reference ranges for fat-soluble vitamins, aiding in the early detection and management of related health issues.
How similar studies have performed: While there have been studies on individual fat-soluble vitamins, this comprehensive approach in the Chinese population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Zhong Liu — First Affiliated Hospital of Zhejiang University
- Study coordinator: Zhong Liu
- Email: liuzhongzheyi@zju.edu.cn
- Phone: +86 13957104885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.