Beneficial Effects of Long Term Menaquinone-7

Bone Loss Clinical Trial

Official title:

Clinical Trial on Beneficial Effects of Long Term Menaquinone-7 (Vitamin K2) Intake by Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642551
• Other study ID #: 07-3-074
• Status: Completed
• Phase: N/A
• First received: March 19, 2008
• Last updated: June 11, 2012
• Start date: March 2008
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 65 Years

Eligibility

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 cortico?d 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Bone Loss

Intervention

Dietary Supplement:
• menaquinone-7
180 µg menaquinone-7 daily for three years
• placebo
1 placebo capsule daily for three years

Locations

Country	Name	City	State
Netherlands	VitaK BV / Maastricht University	Maastricht	PO Box 616

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)		three years	No