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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928134
• Other study ID #: VitK2
• Status: Completed
• Phase: N/A
• First received: August 19, 2013
• Last updated: August 22, 2013
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: August 2013
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Calcinosis
• Healthy
• Osteoporosis

Intervention

Dietary Supplement:
• Vit K2+ Vit D3+ calcium carbonate (CaCO3)

• Vit K2+CaCO3

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in serum Parathyroid hormone(PTH)		at 4 hour after intake	No
Primary	Change from baseline in Serum Calcium		at 4 hours after intake	No
Secondary	Change from baseline in urine calcium/creatinine ratio		at 4 hours after intake	No