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NOT YET RECRUITING
NCT07041645
NA

Bioavailability of Different Vitamin K Vitamers Studied Using 13C-labelled Vitamin K Vitamers

Sponsor: University of Copenhagen

View on ClinicalTrials.gov

Summary

Objectives The main objectives are: Study part I: to investigate the bioavailability of vitamin K vitamers (PK, MK-4, MK-7 and MK-9) in humans using 13C-labelled compounds Hypotheses Study part I: it is hypothesized that there is a difference between the bioavailability of the different vitamers, with MK-9 having the highest bioavailability followed by MK-7, and then PK, while MK-4 will have the lowest bioavailability. Participants will: Study part I: In the pilot study and study part I, participants will visit NEXS for a test period where a 6.5-hour test day will be carried out and followed up with two short visits on the 2 consecutive days. In the pilot study, there will be one test period with frequent blood sampling (before and after ingestion of a labelled vitamin K vitamer) and urine and faeces sampling. The minimum duration for each participant in the pilot study will be 2.5 weeks. After analyses of the bioavailability of the vitamin K vitamers in the pilot study, results will be used to determine the time points for biological sampling (mainly blood) in study part I. Study part I is a cross-over study with 4 test periods and washout periods in between. The minimum duration for each participant will be 6 weeks.

Official title: Bioavailability of Micronutrients With a Special Focus on Vitamin K - Study Part I: K-vitamin

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-07-01

Completion Date

2031-06-30

Last Updated

2025-06-27

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Vitamin K

each participant will recive one dose of each of the four vitamin K vitamers but in different orders (4 different orders).

Locations (1)

University of Copenhagen

Frederiksberg C, Denmark