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BioMicroMicronutrient Bioavailability Study: Vitamin K Focus

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Study Aim

This study examines how our body processes different forms of vitamin K by comparing 13C-labelled vitamin K vitamers in your blood, urine, and fecal samples.

What is being tested

Vitamin K

Dietary Supplement
Who is being recruted

From 18 to 65 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorUniversity of Copenhagen
Study ContactSusanne Gjedsted Bügel, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

This study investigates how different forms of vitamin K are absorbed in the body. Vitamin K is essential for blood clotting and bone health. The study focuses on four specific types of vitamin K, referred to as vitamers: 13C-PK, 13C-MK-4, 13C-MK-7, and 13C-MK-9. Understanding the bioavailability, or how well these vitamins are absorbed, could help improve dietary recommendations and supplement formulations, particularly for those who may have deficiencies or need specific types of vitamin K for health reasons. Participants in the study follow specific instructions to prepare, such as avoiding certain foods like sweet corn, beetroot, and spinach, and taking a vitamin D supplement. During the test periods, participants fast and then consume a meal containing a labeled vitamin K vitamer. Blood samples are taken at various intervals after the meal to track how the vitamin is absorbed over time. The study involves several test periods, and between these periods, participants have washout periods where they refrain from consuming the labeled vitamin K to prevent overlap. This research could provide valuable insights into which forms of vitamin K are most beneficial and how to optimize their use.

Official TitleBioavailability of Micronutrients With a Special Focus on Vitamin K - Study Part I: K-vitamin
NCT07041645
Principal SponsorUniversity of Copenhagen
Study ContactSusanne Gjedsted Bügel, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Men and women

Between 18 and 65 years old (including both 18 and 65 year olds)

Danish-speaking

Willingness to consume/comply with consumption of study-related intervention products/diet

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18 exclusion criteria prevent from participating
Daily smokers/users of all kinds of nicotine-containing products. Occasional smokers/user can be included if they are willing to refrain from all kinds of nicotine-containing products during the trial (from screening to end of trial)

Blood donation <3 months prior to study-related blood sampling

Intensive physical training (> 10 hours of strenuous physical activity per week)

Participation in other clinical studies at the time of the study

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The participants will receive one dose of 13C-MK-4 and the levels in blood, urine and feces will be analyzed

Group II

Experimental
The participants will receive one dose of 13C-MK-7 and the levels in blood, urine and feces will be analyzed

Group III

Experimental
The participants will receive one dose of 13C-MK-9 and the levels in blood, urine and feces will be analyzed

Group IV

Experimental
The participants will receive one dose of 13C-PK and the levels in blood, urine and feces will be analyzed

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Copenhagen

Frederiksberg C, DenmarkOpen University of Copenhagen in Google Maps
Recruiting soonOne Study Center