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

NCT07041645 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-27

No results posted yet for this study

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.

Conditions

  • Bioavailability of Vitamin K

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).

Sponsors & Collaborators

  • Technical University of Denmark

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Susanne G Bügel, Professor · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-12-31
Completion
2031-06-30

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07041645 on ClinicalTrials.gov