Clinical trial NCT00642551: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Arteriosclerosis
Keywords: vitamin K2
menaquinone-7
bone health
vascular health
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-03-25
Enrollment: 240
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound
timeFrame: three years
Secondary outcomes:
measure: The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)
timeFrame: three years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: VitaK BV / Maastricht University
state: PO Box 616
Study officials:
affiliation: Maastricht University
name: Cees Vermeer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.