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NCT Number: NCT06512688

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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