NCT06512688

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Fat Soluble Vitamin Deficiencies and Disorders

Interventions

Type	Name	Description
OTHER	—	This is a cross-sectional study without intervention.

Timeline

• Start date: 2024-07-03
• Primary completion: 2026-06-30
• Completion: 2026-08-02
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: China