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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Vit K2+ Vit D3+ calcium carbonate (CaCO3); Dietary supplement: Vit K2+CaCO3

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Vit K2+ Vit D3+ calcium carbonate (CaCO3)	Dietary supplement: Vit K2+ Vit D3+ calcium carbonate (CaCO3)
ACTIVE_COMPARATOR: B; Vit K2+CaCO3	Dietary supplement: Vit K2+CaCO3

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Change from baseline in serum Parathyroid hormone(PTH)	at 4 hour after intake

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital
• Investigators: Principal Investigator: Shih-Li Su, MD, Changhua Christian Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (ESTIMATE): August 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: volunteers; Vitamin D3; Men; Vitamin K2; Bioavailability of calcium; non-pregnant women; twenty years of age
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate
• Other Study ID Numbers: VitK2