Preliminary Establishment of the Medical Reference Range of Serum Vitamin K2 in Chinese Healthy Adults

Health, Subjective Clinical Trial

Official title:

Preliminary Establishment of the Medical Reference Range of Serum Vitamin K2 in Chinese Healthy Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05436483
• Other study ID #: M2022008
• Status: Not yet recruiting
• Start date: July 31, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2022
• Source: Peking University Third Hospital
• Contact: Qi Liu, Ph. D.
• Phone: +8615501060136
• Email: liuqicpu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Osteocalcin is a type of vitamin K2-dependent protein, and many studies have confirmed that vitamin K2 has anti-osteoporosis effects, and has preventive and therapeutic effects on a variety of diseases such as nervous system, cardiovascular disease, immune disease, and glucose metabolism. However, as a pleiotropic vitamin and nutrient, vitamin K2 does not have an exact normal range like other vitamins, when it needs to be supplemented, and in what regimen. Different organizations have different opinions on the recommended intake of vitamin K. Thus, this study intends to preliminarily obtain the reference interval of serum vitamin K2 by conducting clinical research in healthy people in the Beijing-Tianjin-Hebei region, and analyzes different factors, such as gender, age, and place of residence, to compare their level differences and changing trends, and to provide data reference for the recommended intake of vitamin K2 for people with vitamin K2 deficiency.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 465
• Est. completion date: August 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• People aged over 18.

• People with normal routine blood test.

• Willing to participate in this study.

Exclusion Criteria:

• Subjects with congenital metabolic problems and endocrine diseases.

• Treatment with any investigational drug within the past 3 months.

Related Conditions & MeSH terms

• Health, Subjective

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of vitamin K2	Vitamin K2 concentration in serum	During the procedure of regular physical checkups