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Dose-finding Study for Vitamin K2 in Human Volunteers

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ClinicalTrials.gov Identifier: NCT00483431
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins, Menaquinone-7 (MK7) has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains which dosage of MK7 leads to optimal carboxylation levels of these proteins.

The primary objective of this double-blind randomized intervention study is to establish the optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.


Condition or disease Intervention/treatment Phase
Vitamin K-status Dietary Supplement: Placebo Dietary Supplement: MK7 Not Applicable

Detailed Description:

This study is a double-blind randomized intervention study. In total 42 healthy volunteers (men and women) between 18 and 45 years will be recruited among the Maastricht University community (coworkers/students) and randomized into one of the following groups:

Placebo, 10 mcg MK7, 20 mcg MK7, 45 mcg MK7, 90 mcg MK7, 180 mcg MK7, 360 mcg MK7.

Each group will consist of 6 volunteers with approximately equal numbers of men and women (3 men / 3 women). A double-blind design of the study is chosen to avoid the occurrence of bias during the study. The randomization procedure will be performed by an investigator who is not involved in the coordination of the study and will generate specific randomization codes for each subject. After randomization, the volunteers consume the indicated amount of capsules once daily with either breakfast of dinner during a period of 12 weeks.

During the first week, blood samples of the volunteers will be collected at day 0, 1, 3 and 7 to study immediate effects on carboxylation of OC and MGP. After the first week, blood samples will be drawn every first day of week 2, 4, 6, 8, 10, and 12.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose-finding Study for Vitamin K2 in Human Volunteers
Study Start Date : May 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Menadione

Arm Intervention/treatment
Placebo Comparator: PLACEBO
MK7 dosage 0 mcg, 4 capsules, orally, daily for 12 weeks.
Dietary Supplement: Placebo
Active Comparator: MK7_10
MK7 dosage 10 mcg, 1 capsule of 10 mcg and 3 placebo-capsules, orally, daily for 12 weeks.
Dietary Supplement: MK7
Other Name: Menaquinone-7

Active Comparator: MK7_20
MK7 dosage 20 mcg, 2 capsules of 10 mcg and 2 placebo-capsules, orally, daily for 12 weeks.
Dietary Supplement: MK7
Other Name: Menaquinone-7

Active Comparator: MK7_45
MK7 dosage 45 mcg, 1 capsules of 45 mcg and 3 placebo-capsules, orally, daily for 12 weeks.
Dietary Supplement: MK7
Other Name: Menaquinone-7

Active Comparator: MK7_90
MK7 dosage 90 mcg, 2 capsules of 45 mcg and 2 placebo-capsules, orally, daily for 12 weeks.
Dietary Supplement: MK7
Other Name: Menaquinone-7

Active Comparator: MK7_180
MK7 dosage 180 mcg, 4 capsules of 45 mcg, orally, daily for 12 weeks.
Dietary Supplement: MK7
Other Name: Menaquinone-7

Active Comparator: MK7_360
MK7 dosage 360 mcg, 1 capsule of 360 mcg and 3 placebo-capsules, orally, daily for 12 weeks.
Dietary Supplement: MK7
Other Name: Menaquinone-7




Primary Outcome Measures :
  1. undercarboxylated osteocalcin (ucOC) [ Time Frame: 12 weeks ]
    UcOC will be assessed by making use of a sandwich ELISA (in ng/ml)


Secondary Outcome Measures :
  1. carboxylated osteocalcin (cOC) [ Time Frame: 12 weeks ]
    cOC will be assessed by making use of a sandwich ELISA (in ng/ml)

  2. undercarboxylated matrix-gla protein (ucMGP) [ Time Frame: 12 weeks ]
    ucMGP will be assessed by making use of a sandwich ELISA (in pM)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female adults between 18 and 45 years of age.
  • Subjects of normal body weight and height according to BMI < 30
  • Subject has given written consent to take part in the study

Exclusion Criteria:

  • Subjects with (a history of) metabolic or gastrointestinal disease
  • Subject with (a history of) soy allergy
  • Subjects using vitamin supplements containing vitamin K
  • Subjects presenting chronic inflammatory diseases
  • Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
  • Subjects receiving corticoϊd treatment
  • Subjects using oral anticoagulants

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): NCT00483431


Locations
Netherlands
VitaK BV / University of Maastricht
Maastricht, PO Box 616, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Cees Vermeer, PhD Maastricht University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00483431     History of Changes
Other Study ID Numbers: MEC 07-3-014
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: March 2009

Keywords provided by Maastricht University Medical Center:
vitamin K2
dosis-response
osteocalcin
matrix-gla protein

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