Beneficial Effects of Long Term Menaquinone-7

• ClinicalTrials.gov Identifier: NCT00642551
• Recruitment Status: Completed
• First Posted: March 25, 2008
• Last Update Posted: June 12, 2012
• Sponsor: Maastricht University Medical Center
• Information provided by (Responsible Party): Maastricht University Medical Center

Tracking Information

• First Submitted Date: March 19, 2008
• First Posted Date: March 25, 2008
• Last Update Posted Date: June 12, 2012
• Study Start Date: March 2008
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 19, 2008): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 19, 2008): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Bone Loss
• Arteriosclerosis

Intervention

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

Study Arms

• Active Comparator: MK-7
  1 capsule per day existing of 180 µg menaquinone-7
  Intervention: Dietary Supplement: menaquinone-7
• Placebo Comparator: Placebo
  1 placebo capsule per day for three years
  Intervention: Dietary Supplement: placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 19, 2008): 240
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 55 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00642551
• Other Study ID Numbers: 07-3-074
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Maastricht University Medical Center
• Original Responsible Party: Dr. C. Vermeer, VitaK BV
• Current Study Sponsor: Maastricht University Medical Center
• Original Study Sponsor: Maastricht University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Cees Vermeer, PhD; Maastricht University

• PRS Account: Maastricht University Medical Center
• Verification Date: June 2012