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

August 22, 2013 updated by: Shih-Li Su, Changhua Christian Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: at 4 hours after intake
at 4 hours after intake

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitK2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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