NCT01638143

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

2 months

First QC Date

July 9, 2012

Last Update Submit

July 10, 2012

Conditions

BioequivalenceBioavailability

Keywords

vitamin K2menaquinone-7bioavailability

Outcome Measures

Primary Outcomes (1)

  • MK-7 absorption profiles

    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.

    9 weeks

Study Arms (3)

Gnosis P-1000 capsules

ACTIVE COMPARATOR

MK-7 capsules containing 75 µg of MK-7 (source: Gnosis, Italy).

Dietary Supplement: Gnosis P-1000 capsules

Gnosis M1500 capsules

ACTIVE COMPARATOR

MK-7 capsules containing 75 µg of MK-7 (source Gnosis, Italy).

Dietary Supplement: Gnosis M-1500 capsules

MenaQ7 M-1500 capsules

ACTIVE COMPARATOR

MK-7 capsules containing 75 µg of MK-7 (source: Nattopharma, Norway)

Dietary Supplement: MenaQ7 M-1500 capsulesDietary Supplement: Gnosis P-1000 capsules

Interventions

MenaQ7 M-1500 capsulesDIETARY_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.

MenaQ7 M-1500 capsules
Gnosis P-1000 capsulesDIETARY_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 capsulesMenaQ7 M-1500 capsules
Gnosis M-1500 capsulesDIETARY_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 M1500 capsules

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VitaK BV / Maastricht University Medical Center

Maastricht, Netherlands

Location

Study Officials

  • Cees Vermeer, PhD

    VitaK BV Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

November 1, 2010

Primary Completion

January 1, 2011

Study Completion

August 1, 2011

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

NL(1)