HealthyNCT01928134
The Efficacy of Vitamin K2 n Human Osteoporosis, Blood-vessel Calcification and Sclerosis
A study testing Vit K2+ Vit D3+ calcium carbonate (CaCO3) and Vit K2+CaCO3 in people with Healthy, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vit K2+ Vit D3+ calcium carbonate (CaCO3) and Vit K2+CaCO3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Vit K2+ Vit D3+ calcium carbonate (CaCO3), Vit K2+CaCO3
- Keywords
- Vitamin K2, Vitamin D3, Bioavailability of calcium, volunteers, Men, non-pregnant women, twenty years of age
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit K2+ Vit D3+ calcium carbonate (CaCO3)Dietary supplement
Vit K2+CaCO3Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Vit K2+ Vit D3+ calcium carbonate (CaCO3) Receives: Dietary Supplement: Vit K2+ Vit D3+ calcium carbonate (CaCO3) |
| B | Active comparator | Vit K2+CaCO3 Receives: Dietary Supplement: Vit K2+CaCO3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Serum Calcium
Measured: at 4 hours after intake
Secondary outcomes (1)
Change from baseline in urine calcium/creatinine ratio
Measured: at 4 hours after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startApr 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-Li Su, Changhua Christian Hospital
- Investigators
- Shih-Li Su, MD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928134
- Sponsor's protocol ID
- VitK2
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Vitamin K2 on Human Osteoporosis, Blood-vessel Calcification and Sclerosis
- ClinicalTrials.gov ID
- NCT01928134
- Acronym / sponsor ID
- VitK2
- Conditions
- Healthy
- Keywords
- Vitamin K2, Vitamin D3, Bioavailability of calcium, volunteers, Men, non-pregnant women, twenty years of age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Vit K2+ Vit D3+ calcium carbonate (CaCO3)Vit K2+ Vit D3+ calcium carbonate (CaCO3) |
| B | Active comparator | Dietary Supplement: Vit K2+CaCO3Vit K2+CaCO3 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vit K2+ Vit D3+ calcium carbonate (CaCO3) | Dietary supplement | A |
| Vit K2+CaCO3 | Dietary supplement | B |
Primary outcome
Change from baseline in Serum Calcium
Time frame: at 4 hours after intake
1 secondary outcome
Change from baseline in urine calcium/creatinine ratio
Time frame: at 4 hours after intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Li Su, MD principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vit K2+ Vit D3+ calcium carbonate (CaCO3) and Vit K2+CaCO3 in people with Healthy, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Serum Calcium (time frame: at 4 hours after intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.