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

NCT06512688 | Recruiting

• 1 other identifier: 20240364
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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 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

Fat Soluble Vitamin Deficiencies and Disorders

Keywords

Reference Interval; Healthy Chinese Adults

Outcome Measures

Primary Outcomes (4)

• serum vitamin A

  day 1

• serum vitamin D

  day 1

• serum vitamin E

  day 1

• serum vitamin K

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 and above who underwent physical examinations in collaborating hospitals from July 2024 to June 2026.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Huizhou Municipal Central Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator
• Affiliated Yueqing Hospital of Wenzhou Medical University: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Affiliated Hangzhou First People's Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Lu'an People's Hospital of Anhui Province: collaborator
• Shandong Provincial Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Changzhi Medical College: collaborator
• LinFen People's Hospital: collaborator
• The Second Affiliated Hospital of Chongqing Medical University: collaborator
• Yulin No.2 Hospital: collaborator
• Hanzhong Central Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhong Liu

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong Liu

CONTACT

+86 13957104885; liuzhongzheyi@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Health Management Center

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 22, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)