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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Vit K2+ Vit D3+ calcium carbonate (CaCO3); Dietary Supplement: Vit K2+CaCO3

• Registration Number: NCT01928134
• Lead Sponsor: Changhua Christian Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-11
• Study Completion: 2012-02
• Status Verified: 2013-08
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-22
• Last Update Submitted: 2013-08-22
• Study First Posted: 2013-08-23
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Vit K2+ Vit D3+ calcium carbonate (CaCO3)	Vit K2+ Vit D3+ calcium carbonate (CaCO3)
B	Vit K2+CaCO3	Vit K2+CaCO3

Primary Outcome Measures

Name	Time	Method
Change from baseline in Serum Calcium	at 4 hours after intake

Secondary Outcome Measures

Name	Time	Method
Change from baseline in urine calcium/creatinine ratio	at 4 hours after intake

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan