Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2010-11-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Gnosis P-1000 capsules
MK-7 capsules containing 75 µg of MK-7 (source: Gnosis, Italy).
Gnosis P-1000 capsules
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
MK-7 capsules containing 75 µg of MK-7 (source Gnosis, Italy).
Gnosis M-1500 capsules
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
MK-7 capsules containing 75 µg of MK-7 (source: Nattopharma, Norway)
MenaQ7 M-1500 capsules
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
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.
Interventions
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MenaQ7 M-1500 capsules
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
20 Years
40 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Cees Vermeer, PhD
Role: PRINCIPAL_INVESTIGATOR
VitaK BV Maastricht University
Locations
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VitaK BV / Maastricht University Medical Center
Maastricht, , Netherlands
Countries
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Other Identifiers
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10-3-017
Identifier Type: -
Identifier Source: org_study_id
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