Clinical trial NCT01928134: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Vitamin K2
Vitamin D3
Bioavailability of calcium
volunteers
Men
non-pregnant women
twenty years of age
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Serum Calcium
timeFrame: at 4 hours after intake
Secondary outcomes:
measure: Change from baseline in urine calcium/creatinine ratio
timeFrame: at 4 hours after intake
Other outcomes:
measure: Change from baseline in serum Parathyroid hormone(PTH)
timeFrame: at 4 hour after intake
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital
name: Shih-Li Su, MD
role: PRINCIPAL_INVESTIGATOR
References: