NCT00483431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 27, 2018

Status Verified

March 1, 2009

Enrollment Period

5 months

First QC Date

June 6, 2007

Last Update Submit

April 26, 2018

Conditions

Vitamin K-status

Keywords

vitamin K2dosis-responseosteocalcinmatrix-gla protein

Outcome Measures

Primary Outcomes (1)

  • undercarboxylated osteocalcin (ucOC)

    UcOC will be assessed by making use of a sandwich ELISA (in ng/ml)

    12 weeks

Secondary Outcomes (2)

  • carboxylated osteocalcin (cOC)

    12 weeks

  • undercarboxylated matrix-gla protein (ucMGP)

    12 weeks

Study Arms (7)

PLACEBO

PLACEBO COMPARATOR

MK7 dosage 0 mcg, 4 capsules, orally, daily for 12 weeks.

Dietary Supplement: Placebo

MK7_10

ACTIVE COMPARATOR

MK7 dosage 10 mcg, 1 capsule of 10 mcg and 3 placebo-capsules, orally, daily for 12 weeks.

Dietary Supplement: MK7

MK7_20

ACTIVE COMPARATOR

MK7 dosage 20 mcg, 2 capsules of 10 mcg and 2 placebo-capsules, orally, daily for 12 weeks.

Dietary Supplement: MK7

MK7_45

ACTIVE COMPARATOR

MK7 dosage 45 mcg, 1 capsules of 45 mcg and 3 placebo-capsules, orally, daily for 12 weeks.

Dietary Supplement: MK7

MK7_90

ACTIVE COMPARATOR

MK7 dosage 90 mcg, 2 capsules of 45 mcg and 2 placebo-capsules, orally, daily for 12 weeks.

Dietary Supplement: MK7

MK7_180

ACTIVE COMPARATOR

MK7 dosage 180 mcg, 4 capsules of 45 mcg, orally, daily for 12 weeks.

Dietary Supplement: MK7

MK7_360

ACTIVE COMPARATOR

MK7 dosage 360 mcg, 1 capsule of 360 mcg and 3 placebo-capsules, orally, daily for 12 weeks.

Dietary Supplement: MK7

Interventions

PlaceboDIETARY_SUPPLEMENT
PLACEBO
MK7DIETARY_SUPPLEMENT
Also known as: Menaquinone-7
MK7_10MK7_180MK7_20MK7_360MK7_45MK7_90

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VitaK BV / University of Maastricht

Maastricht, PO Box 616, 6200 MD, Netherlands

Location

Related Publications (2)

  • Theuwissen E, Cranenburg EC, Knapen MH, Magdeleyns EJ, Teunissen KJ, Schurgers LJ, Smit E, Vermeer C. Low-dose menaquinone-7 supplementation improved extra-hepatic vitamin K status, but had no effect on thrombin generation in healthy subjects. Br J Nutr. 2012 Nov 14;108(9):1652-7. doi: 10.1017/S0007114511007185. Epub 2012 Jan 31.

    PMID: 22289649DERIVED

  • Knapen MH, Schurgers LJ, Shearer MJ, Newman P, Theuwissen E, Vermeer C. Association of vitamin K status with adiponectin and body composition in healthy subjects: uncarboxylated osteocalcin is not associated with fat mass and body weight. Br J Nutr. 2012 Sep 28;108(6):1017-24. doi: 10.1017/S000711451100626X. Epub 2011 Dec 5.

    PMID: 22136751DERIVED

MeSH Terms

Interventions

menaquinone 7

Study Officials

  • Cees Vermeer, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 7, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

April 27, 2018

Record last verified: 2009-03

Locations

NL(1)