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Beneficial Effects of Long Term Menaquinone-7

Primary Purpose

Bone Loss, Arteriosclerosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
menaquinone-7
placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss focused on measuring vitamin K2, menaquinone-7, bone health, vascular health

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • VitaK BV / Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MK-7

Placebo

Arm Description

1 capsule per day existing of 180 µg menaquinone-7

1 placebo capsule per day for three years

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2008
Last Updated
June 11, 2012
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00642551
Brief Title
Beneficial Effects of Long Term Menaquinone-7
Official Title
Clinical Trial on Beneficial Effects of Long Term Menaquinone-7 (Vitamin K2) Intake by Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Arteriosclerosis
Keywords
vitamin K2, menaquinone-7, bone health, vascular health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MK-7
Arm Type
Active Comparator
Arm Description
1 capsule per day existing of 180 µg menaquinone-7
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 placebo capsule per day for three years
Intervention Type
Dietary Supplement
Intervention Name(s)
menaquinone-7
Intervention Description
180 µg menaquinone-7 daily for three years
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
1 placebo capsule daily for three years
Primary Outcome Measure Information:
Title
Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound
Time Frame
three years
Secondary Outcome Measure Information:
Title
The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)
Time Frame
three years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cees Vermeer, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VitaK BV / Maastricht University
City
Maastricht
State/Province
PO Box 616
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22136751
Citation
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.
Results Reference
derived

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Beneficial Effects of Long Term Menaquinone-7

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