NCT01638143

Bio-equivalence Study

Comparison of Bioavailability of Three Different Vitamin K2 Formulations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Bioequivalence
• Bioavailability

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-01-01
• Completion: 2011-08-01
• First posted: 2012-07-11
• Last updated: 2012-07-11

Locations

1 site across 1 country: Netherlands