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Status unknownNCT06512688Updated Jul 22, 2024

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

An observational study in Fat Soluble Vitamin Deficiencies and Disorders, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by First Affiliated Hospital of Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 vitamins (FSVs). The primary FSVs include vitamins A, D, E, and K, which are absorbed in the intestines in the presence of dietary fat.

The balance of these vitamins in the body is vital for health. Deficiencies or excesses can lead to significant health issues. For example, a deficiency in vitamin A can cause night blindness, a lack of vitamin D can lead to osteomalacia, insufficient vitamin E can result in increased oxidative stress in cells, and a deficiency in vitamin K can cause bleeding disorders.

Globally, research on FSVs in healthy populations is usually focused on specific vitamins or limited to particular regions and demographics. Consequently, there is a scarcity of comprehensive data on the concentration of all four FSVs at the population level. In China, there has been no extensive study that simultaneously analyzes the levels of all four FSVs in a healthy adult population.

This study addresses this gap through a multicenter approach, collecting data on the levels of vitamins A, D, E, and K from healthy adults across various regions in China. The goal is to establish a reference range for serum FSV levels in Chinese adults. This database will serve as a scientific foundation for accurately assessing FSV levels in clinical settings and providing early intervention for diseases related to FSV imbalances. Additionally, this research aims to enhance understanding of the nutritional status of the Chinese population and guide dietary recommendations and public health policies to improve overall health outcomes.

02

Conditions studied

  • Fat Soluble Vitamin Deficiencies and Disorders

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Keywords

  • Reference Interval
  • Healthy Chinese Adults
03

In context

Disease

1,382 studies on the registry are indexed under Disease; 612 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 209 across 598 observational studies indexed under Disease.

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Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 260 studies on the registry; 141 are open to participants now.

Browse First Affiliated Hospital of Zhejiang University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. serum vitamin A

    Time frame: day 1

  2. serum vitamin D

    Time frame: day 1

  3. serum vitamin E

    Time frame: day 1

  4. serum vitamin K

    Time frame: day 1

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Zhejiang University
    Hangzhou, Zhejiang 310003, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Jun 2026, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2024
First posted
Jul 22, 2024
StartActual
Jul 3, 2024
Primary completionEst.
Jun 30, 2026
CompletionEst.
Aug 2, 2026
Last update
Jul 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06512688
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Huizhou Municipal Central Hospital, Affiliated Hospital of Jiaxing University, Zhejiang Provincial Tongde Hospital, Affiliated Yueqing Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Zhejiang Provincial People's Hospital, First People's Hospital of Hangzhou, Ningbo Medical Center Lihuili Hospital, Lu'an People's Hospital of Anhui Province, Shandong Provincial Hospital, Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Nanchang University, Nanfang Hospital, Southern Medical University, The Third Xiangya Hospital of Central South University, Changzhi Medical College, Linfen No.4 People's Hospital, The Second Affiliated Hospital of Chongqing Medical University, Yulin No.2 Hospital, Hanzhong Central Hospital
Responsible party
Liu Zhong (Head of Health Management Center, First Affiliated Hospital of Zhejiang University) — Principal investigator
First posted
Jul 22, 2024
Start date
Jul 3, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Aug 2, 2026 (estimated)
Last update
Jul 22, 2024

Study contacts

Zhong Liu
Contact
liuzhongzheyi@zju.edu.cn
+86 13957104885
Zhong Liu
principal investigator · First Affiliated Hospital of Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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