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Beneficial Effects of Long Term Menaquinone-7

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00642551
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : June 12, 2012
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Bone Loss Arteriosclerosis Dietary Supplement: menaquinone-7 Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial on Beneficial Effects of Long Term Menaquinone-7 (Vitamin K2) Intake by Postmenopausal Women
Study Start Date : March 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Menadione

Arm Intervention/treatment
Active Comparator: MK-7
1 capsule per day existing of 180 µg menaquinone-7
Dietary Supplement: menaquinone-7
180 µg menaquinone-7 daily for three years

Placebo Comparator: Placebo
1 placebo capsule per day for three years
Dietary Supplement: placebo
1 placebo capsule daily for three years




Primary Outcome Measures :
  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 [ Time Frame: three years ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642551


Locations
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Netherlands
VitaK BV / Maastricht University
Maastricht, PO Box 616, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Cees Vermeer, PhD Maastricht University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00642551    
Other Study ID Numbers: 07-3-074
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012
Keywords provided by Maastricht University Medical Center:
vitamin K2
menaquinone-7
bone health
vascular health
Additional relevant MeSH terms:
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Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamin K 2
Vitamin K
Vitamin MK 7
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs