Bio-equivalence Study

Comparison of Bioavailability of Three Different Vitamin K2 Formulations

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

Study Overview

• Status: Completed
• Conditions: Bioavailability; Bioequivalence
• Intervention / Treatment: Dietary supplement: Gnosis P-1000 capsules; Dietary supplement: Gnosis M-1500 capsules; Dietary supplement: MenaQ7 M-1500 capsules

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Vitak BV / Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Gnosis P-1000 capsules; MK-7 capsules containing 75 µg of MK-7 (source: Gnosis, Italy).	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.
ACTIVE_COMPARATOR: Gnosis M1500 capsules; MK-7 capsules containing 75 µg of MK-7 (source Gnosis, Italy).	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.
ACTIVE_COMPARATOR: MenaQ7 M-1500 capsules; MK-7 capsules containing 75 µg of MK-7 (source: Nattopharma, Norway)	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (ESTIMATE): July 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: bioavailability; menaquinone-7; vitamin K2
• Other Study ID Numbers: 10-3-017