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Trial record 35 of 50 for:    vitamin k2

Bio-equivalence Study

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ClinicalTrials.gov Identifier: NCT01638143
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Bioequivalence Bioavailability Dietary Supplement: MenaQ7 M-1500 capsules Dietary Supplement: Gnosis P-1000 capsules Dietary Supplement: Gnosis M-1500 capsules Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Bioavailability of Three Different Vitamin K2 Formulations
Study Start Date : November 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K

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: 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.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638143


Locations
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Netherlands
VitaK BV / Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Cees Vermeer, PhD VitaK BV Maastricht University

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01638143     History of Changes
Other Study ID Numbers: 10-3-017
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012
Keywords provided by Maastricht University Medical Center:
vitamin K2
menaquinone-7
bioavailability
Additional relevant MeSH terms:
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Vitamin K
Vitamin K 2
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants