Clincosm LogoSign in Get a demo

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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05436483
Collaborator
(none)
465
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

Brief 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

  1. 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.
Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    465 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Preliminary Establishment of the Medical Reference Range of Serum Vitamin K2 in Chinese Healthy Adults
    Anticipated Study Start Date :
    Jul 31, 2022
    Anticipated Primary Completion Date :
    Jul 30, 2023
    Anticipated Study Completion Date :
    Aug 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Concentration of vitamin K2 [During the procedure of regular physical checkups]

      Vitamin K2 concentration in serum

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT05436483
    Other Study ID Numbers:
    • M2022008
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 29, 2022