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

NCT ID: NCT01928134

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-02-29

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.

Detailed Description

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Conditions

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Healthy

Keywords

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Vitamin K2 Vitamin D3 Bioavailability of calcium volunteers Men non-pregnant women twenty years of age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Vit K2+ Vit D3+ calcium carbonate (CaCO3)

Group Type EXPERIMENTAL

Vit K2+ Vit D3+ calcium carbonate (CaCO3)

Intervention Type DIETARY_SUPPLEMENT

B

Vit K2+CaCO3

Group Type ACTIVE_COMPARATOR

Vit K2+CaCO3

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vit K2+ Vit D3+ calcium carbonate (CaCO3)

Intervention Type DIETARY_SUPPLEMENT

Vit K2+CaCO3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Men and non-pregnant women who are at least 20 years and under 75 years of age; and
2. Female subjects cannot be pregnant or breast feeding.
3. Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and
4. 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

1. Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding.
2. Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks.
3. Recent myocardial infarction (within the prior 12 weeks).
4. Unstable angina pectoris.
5. Known or suspected renal insufficiency defined as creatinine\>1.5mg/dl.
6. Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) \>3x upper normal limit (i.e., 120 U/l).
7. Known hypomotility syndrome: (such as hypothyroidism or scleroderma).
8. Recent major trauma within the prior 12 weeks.
9. Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks).
10. Recent hospitalization (within 12 weeks)
11. Uncontrolled hypertension (defined as a systolic blood pressure\>180mmHg or a diastolic blood pressure \>105mmHg).
12. Uncontrolled hyperlipidemia (defined as total cholesterol\>240mg/dL or triglyceride \>200mg/dL).
13. Uncontrolled diabetes (defined as HbA1c\>7%).
14. Cigarette smoker (\>=1/day).
15. Acute infection requiring current antibiotic therapy.
16. Current use of anticoagulant medication (e.g., warfarin).
17. Recent or abrupt change (within 1 month) in usual diet.
18. Use of an investigational drug (within 30 days prior to enrollment).
19. Known allergies to the component of study medication
20. Patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shih-Li Su

Attending Physician of Section of Endocrinology and Metabolism

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shih-Li Su, MD

Role: PRINCIPAL_INVESTIGATOR

Changhua Christian Hospital

Locations

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Changhua Christian Hospital

Changhua, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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VitK2

Identifier Type: -

Identifier Source: org_study_id