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Completed

NCT Number: NCT01928134

The Efficacy of Vitamin K2 n 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vit K2+ Vit D3+ calcium carbonate (CaCO3)

Dietary Supplement

Vit K2+CaCO3

Dietary Supplement

Primary outcomes

  1. Change from baseline in Serum Calcium

    Time frame: at 4 hours after intake

Secondary outcomes

  1. Change from baseline in urine calcium/creatinine ratio

    Time frame: at 4 hours after intake

Other outcomes

  1. Change from baseline in serum Parathyroid hormone(PTH)

    Time frame: at 4 hour after intake

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 23, 2013
Registry last updated
Aug 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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