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

NCT07041645 | Not Yet Recruiting

• 1 other identifier: BioMicro Protokol v1.2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bioavailability; vitamin K; 13C-labelled vitamin K

Outcome Measures

Primary Outcomes (3)

• 13C-labelled vitamin K vitamers in blood samples

  The area under the curve for the different 13C-labelled vitamin K vitamers will be compared from blood samples.

  from test day 1 until the end of the last washout period 5 weeks after test day 1.

• 13C-labelled vitamin K vitamers in fecal samples

  The amount of 13C-labelled vitamin K vitamers in the feces will be analysed

  from test day 1 until the end of the last washout period 5 weeks after test day 1.

• 13C-lebelled vitamin K vitamers in urine samples

  The amount of 13C-labelled vitamin K vitamers in the urine will be analysed

  from test day 1 until the end of the last washout period 5 weeks after test day 1.

Study Arms (4)

13C-phylloquinone (13C-PK)

EXPERIMENTAL

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

Dietary Supplement: Vitamin K

13C-menaquinone-4 (13C-MK-4)

EXPERIMENTAL

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

Dietary Supplement: Vitamin K

13C-menaquinone-7 (13C-MK-7)

EXPERIMENTAL

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

Dietary Supplement: Vitamin K

13C-menaquinone-9 (13C-MK-9)

EXPERIMENTAL

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

Dietary Supplement: Vitamin K

Interventions

Vitamin K DIETARY_SUPPLEMENT

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

13C-menaquinone-4 (13C-MK-4); 13C-menaquinone-7 (13C-MK-7); 13C-menaquinone-9 (13C-MK-9); 13C-phylloquinone (13C-PK)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willing to take 10 µg vitamin D3/day and omit intake of all other (vitamins and mineral) supplements before and during the trial
• BMI ≤ 30.0 kg/m2

You may not qualify if:

• 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
• Pregnant, lactating or planning to become pregnant within the study period
• Habitual alcohol intake above current recommendation (\> 10 alcoholic units/week)
• History of cancer within the past five (5) years except basal cell skin cancer and cervix
• Diagnosed with chronic inflammation disorders
• Diagnosed with gastrointestinal diseases
• Diagnosed with bone related diseases
• Diagnosed with psychiatric disorder including depression that requires medical treatment
• Medical treatment of diabetes
• Medical treatment of cardiovascular related disease
• Surgical change of the gastrointestinal tract (removal of appendix is allowed)
• Use of prescription medication that can affect their safety or impact on data

Sponsors & Collaborators

• University of Copenhagen: lead
• Technical University of Denmark: collaborator

Study Sites (1)

University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Interventions

Vitamin K

Intervention Hierarchy (Ancestors)

Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Polycyclic Compounds

Study Officials

• Susanne G Bügel, Professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Gjedsted Bügel, PhD

CONTACT

35332490; shb@nexs.ku.dk

Susanne G Bügel, Professor

CONTACT

35332490; shb@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Section

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 30, 2031
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)