The Efficacy of Vitamin K2 n Human Osteoporosis, Blood-vessel Calcification and Sclerosis

Study Overview
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Brief Summary
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This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis improvement; (4) safety evaluation.

Official Title
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The Efficacy of Vitamin K2 on Human Osteoporosis, Blood-vessel Calcification and Sclerosis

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Vit K2+ Vit D3+ calcium carbonate (CaCO3)
* Dietary Supplement: Vit K2+CaCO3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and non-pregnant women who are at least 20 years and under 75 years of age; and Female subjects cannot be pregnant or breast feeding. Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication. Exclusion Criteria: Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding. Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks. Recent myocardial infarction (within the prior 12 weeks). Unstable angina pectoris. Known or suspected renal insufficiency defined as creatinine>1.5mg/dl. Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) >3x upper normal limit (i.e., 120 U/l). Known hypomotility syndrome: (such as hypothyroidism or scleroderma). Recent major trauma within the prior 12 weeks. Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks). Recent hospitalization (within 12 weeks) Uncontrolled hypertension (defined as a systolic blood pressure>180mmHg or a diastolic blood pressure >105mmHg). Uncontrolled hyperlipidemia (defined as total cholesterol>240mg/dL or triglyceride >200mg/dL). Uncontrolled diabetes (defined as HbA1c>7%). Cigarette smoker (>=1/day). Acute infection requiring current antibiotic therapy. Current use of anticoagulant medication (e.g., warfarin). Recent or abrupt change (within 1 month) in usual diet. Use of an investigational drug (within 30 days prior to enrollment). Known allergies to the component of study medication Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Vit K2+ Vit D3+ calcium carbonate (CaCO3) | Dietary Supplement: Vit K2+ Vit D3+ calcium carbonate (CaCO3)<br> <br> |
| Active Comparator: B<br>Vit K2+CaCO3 | Dietary Supplement: Vit K2+CaCO3<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Serum Calcium |  | at 4 hours after intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine calcium/creatinine ratio |  | at 4 hours after intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin K2, Vitamin D3, Bioavailability of calcium, volunteers, Men, non-pregnant women, twenty years of age