Comparison of Absorption of Vitamin K2

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00742768
First received: August 27, 2008
Last updated: March 9, 2009
Last verified: March 2009
  Purpose

From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.

This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.


Condition Intervention
Healthy
Dietary Supplement: Vitamin K2 in softgel
Dietary Supplement: Vitamin K2 in Gelpell

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Absorption of Vitamin K2 Human Study Gelpell

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
softgel capsules
Dietary Supplement: Vitamin K2 in softgel
4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule
Active Comparator: 2
Gelpell capsules
Dietary Supplement: Vitamin K2 in Gelpell
4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women between 20 and 30 years old
  • Subjects of normal body weight and height according to BMI < 30
  • Subjects of Caucasian race
  • Subject has given written consent to take part in the study

Exclusion Criteria:

  • Subjects with (a history of) metabolic or gastrointestinal disease
  • Subjects presenting chronic degenerative and/or inflammatory disease
  • Subjects receiving corticoϊd treatment
  • Subjects using oral anticoagulants
  • Subject with (a history of) soy allergy
  • Subjects using vitamin K containing multivitamins or vitamin K supplements
  • Subjects with anaemia or subjects who recently donate blood.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742768

Locations
Netherlands
VitaK BV / Maastricht University
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Cees Vermeer, PhD Maastricht University, VitaK BV
  More Information

No publications provided

Responsible Party: Dr. C. Vermeer, VitaK BV
ClinicalTrials.gov Identifier: NCT00742768     History of Changes
Other Study ID Numbers: MEC 08-3-012
Study First Received: August 27, 2008
Last Updated: March 9, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
absorption
encapsulation
menaquinone
Bio-availability

Additional relevant MeSH terms:
Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014