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OpenTrials
Completed

NCT Number: NCT01638143

Bio-equivalence Study

The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VitaK BV / Maastricht University Medical Center

Maastricht, Netherlands

About this study

Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men and women, aged between 20 and 40 years
  • Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2)
  • Stable body weight (weight gain or loss < 3 kg in past 3 mo)
  • Written consent to take part in the study
  • Agreement to adhere to dietary restrictions required by the protocol

Exclusion criteria

  • Abuse of drugs and/or alcohol
  • Use of vitamin supplements containing vitamin K
  • Soy allergy
  • Pregnancy
  • a history of) metabolic or gastrointestinal diseases including hepatic disorders
  • Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure
  • Use of oral anticoagulants
  • Corticoid treatment
  • Subjects with anaemia or subjects who recently donated blood or plasma
  • Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)

Treatment and study plan

MenaQ7 M-1500 capsules

Dietary Supplement

The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):

  • MenaQ7 M-1500 capsule
  • Gnosis P-1000 capsule
  • Gnosis M-1500 capsule

Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.

Gnosis P-1000 capsules

Dietary Supplement

The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):

  • MenaQ7 M-1500 capsule
  • Gnosis P-1000 capsule
  • Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.

Gnosis M-1500 capsules

Dietary Supplement

The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):

  • MenaQ7 M-1500 capsule
  • Gnosis P-1000 capsule
  • Gnosis M-1500 capsule

Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.

Primary outcomes

  1. MK-7 absorption profiles

    Time frame: 9 weeks

    The purpose of this study is to compare the MK-7 absorption profiles after intake of three different vitamin K2 (MK-7) products that are already on the market. The main study parameter is therefore the calculated AUC value from the individual MK-7 absorption profiles.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Comparison of Bioavailability of Three Different Vitamin K2 Formulations

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 11, 2012
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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