NCT00642551

Brief Summary

From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and matrix-Gla protein (in the arterial vessel wall). The question remains whether supplementation with MK-7 also leads to measurable improvements of bone and vascular health. The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of an MK-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 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

March 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

3.5 years

First QC Date

March 19, 2008

Last Update Submit

June 11, 2012

Conditions

Bone LossArteriosclerosis

Keywords

vitamin K2menaquinone-7bone healthvascular health

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound

    three years

Secondary Outcomes (1)

  • The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)

    three years

Study Arms (2)

MK-7

ACTIVE COMPARATOR

1 capsule per day existing of 180 µg menaquinone-7

Dietary Supplement: menaquinone-7

Placebo

PLACEBO COMPARATOR

1 placebo capsule per day for three years

Dietary Supplement: placebo

Interventions

menaquinone-7DIETARY_SUPPLEMENT

180 µg menaquinone-7 daily for three years

MK-7
placeboDIETARY_SUPPLEMENT

1 placebo capsule daily for three years

Placebo

Eligibility Criteria

Age55 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy postmenopausal women between 55 and 65 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

You may not qualify if:

  • Subjects with (a history of) metabolic or gastrointestinal disease
  • Subjects presenting chronic degenerative and/or inflammatory disease
  • Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
  • Subjects receiving corticoϊd treatment
  • Subjects using oral anticoagulants
  • Subject using bisphosphonates
  • Subjects using hormone replacement therapy
  • Subjects undergoing ovariectomy and/or hysterectomy
  • Subject with (a history of) soy allergy
  • Subjects using vitamin K containing multivitamins or vitamin K supplements
  • Subjects who have participated in a clinical study more recently than one month before the current study
  • Subjects who are found to be osteoporotic at baseline (T-score \< -2.5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VitaK BV / Maastricht University

Maastricht, PO Box 616, 6200 MD, Netherlands

Location

Related Publications (1)

  • 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

Conditions

Bone Diseases, MetabolicArteriosclerosis

Interventions

menaquinone 7

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

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
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 25, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

NL(1)