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CompletedNCT01928134Updated Aug 23, 2013

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

An interventional study of Vit K2+ Vit D3+ calcium carbonate (CaCO3) and Vit K2+CaCO3 in Healthy, sponsored by Changhua Christian Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-23.

Sponsored by Changhua Christian Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

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Keywords

  • Vitamin K2
  • Vitamin D3
  • Bioavailability of calcium
  • volunteers
  • Men
  • non-pregnant women
  • twenty years of age
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 60 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Changhua Christian Hospital is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementVit K2+ Vit D3+ calcium carbonate (CaCO3)
  • Dietary supplementVit K2+CaCO3
06

What researchers measure

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

07

Study locations

1 site
  • Changhua Christian Hospital
    Changhua, 500, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01928134
Lead sponsor
Changhua Christian Hospital
Responsible party
Shih-Li Su (Attending Physician of Section of Endocrinology and Metabolism, Changhua Christian Hospital) — Principal investigator
First posted
Aug 23, 2013
Start date
Apr 2011
Primary completion
Nov 2011
Completion
Feb 2012
Last update
Aug 23, 2013

Study contacts

Shih-Li Su, MD
principal investigator · Changhua Christian Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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