Beneficial Effects of Long Term Menaquinone-7
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| ClinicalTrials.gov Identifier: NCT00642551 |
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Recruitment Status :
Completed
First Posted : March 25, 2008
Last Update Posted : June 12, 2012
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Sponsor:
Maastricht University Medical Center
Information provided by (Responsible Party):
Maastricht University Medical Center
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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 |
| 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 |
|---|---|
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Active Comparator: MK-7
1 capsule per day existing of 180 µg menaquinone-7
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Dietary Supplement: menaquinone-7
180 µg menaquinone-7 daily for three years |
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Placebo Comparator: Placebo
1 placebo capsule per day for three years
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Dietary Supplement: placebo
1 placebo capsule daily for three years |
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 [ Time Frame: three years ]
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) [ Time Frame: three years ]
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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
| Netherlands | |
| VitaK BV / Maastricht University | |
| Maastricht, PO Box 616, Netherlands, 6200 MD | |
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
| Principal Investigator: | Cees Vermeer, PhD | Maastricht University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 Menaquinone 7 Antifibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Vitamins Micronutrients Physiological Effects of Drugs |