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

Primary Purpose

Healthy

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Vit K2+ Vit D3+ calcium carbonate (CaCO3)

Vit K2+CaCO3

About this trial

This is an interventional prevention trial for Healthy focused on measuring Vitamin K2, Vitamin D3, Bioavailability of calcium, volunteers, Men, non-pregnant women, twenty years of age

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Changhua Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Vit K2+ Vit D3+ calcium carbonate (CaCO3)

Vit K2+CaCO3

Outcomes

Primary Outcome Measures

Change from baseline in Serum Calcium

Secondary Outcome Measures

Change from baseline in urine calcium/creatinine ratio

Full Information

NCT ID

NCT01928134

First Posted

August 19, 2013

Last Updated

August 22, 2013

Sponsor

Changhua Christian Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01928134

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhua Christian Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Vit K2+ Vit D3+ calcium carbonate (CaCO3)

Arm Title

Arm Type

Active Comparator

Arm Description

Vit K2+CaCO3

Intervention Type

Dietary Supplement

Intervention Name(s)

Vit K2+ Vit D3+ calcium carbonate (CaCO3)

Intervention Type

Dietary Supplement

Intervention Name(s)

Vit K2+CaCO3

Primary Outcome Measure Information:

Title

Change from baseline in Serum Calcium

Time Frame

at 4 hours after intake

Secondary Outcome Measure Information:

Title

Change from baseline in urine calcium/creatinine ratio

Time Frame

at 4 hours after intake

Other Pre-specified Outcome Measures:

Title

Change from baseline in serum Parathyroid hormone(PTH)

Time Frame

at 4 hour after intake

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shih-Li Su, MD

Organizational Affiliation

Changhua Christian Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhua Christian Hospital

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

12. IPD Sharing Statement

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

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