Metabolic Bone DisorderK2vitaNCT01922804
Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification
A study testing K2 vitamin in people with Metabolic Bone Disorder, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aims of the present study are to investigate the effect of vitamin K2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis. Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Bone Disorder
- What is being tested?
- K2 vitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2013to Apr 2018
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postmenopausal women
- 60-80 years
- osteopenia
Who cannot join
- Calcium metabolic, thyroid, liver or kidney disease
- Diabetes
- Obesity
- Myocardial infarction or other arteriosclerotic events
- Angina pectoris
- Vitamin D < 50 nmol/L
Show all 12Show fewer
- Treatment with vitamin K antagonists
- Use of vitamin K supplements in the last month or for more than 3 months at any time
- Treatment with drugs with known effects on bone metabolism or glucose metabolism.
- Smoking in the last 12 months
- Drug or alcohol abuse
- Allergy to calcium, vitamin D or vitamin K.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology and Internal Medicine THG
Aarhus, 8000
About this study
The aims of the present study are to investigate the effect of vitamin K2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis.
Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.
Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.
Read the detailed description
Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.
Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.
- Conditions
- Metabolic Bone Disorder
- Being tested
- K2 vitamin, Placebo
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K2 vitaminDietary supplement
K2 vitamin tablet
PlaceboDietary supplement
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| K2 vitamin | Experimental | K2 vitamin 375 microgram a day for 3 years Receives: Dietary Supplement: K2 vitamin |
| placebo | Placebo comparator | 1 tablet a day for 3 years Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
p-undercarboxylated osteocalcin
Measured: Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial.
Secondary outcomes (5)
Change in bone mineral density
Change in bone mineral density measured by DXA scans (Dual energy x-ray absorptiometry)
Measured: Assessed after 3, 6, 12, 24 and 36 months
Change in arterial stiffness, pulse wave velocity
Change in pulse wave velocity after 6 months.
Measured: Measured at baseline and after 6 months
Change in insulin sensitivity
Change in insulin sensitivity. Determined by HOMA-test (homeostasis model assessment), using fasting plasma glucose and insulin.
Measured: Measured at baseline and after 1 and 12 months.
Change in bone turnover markers
Measured: Measured at baseline, after 1, 3, 6, 12, 24 and 36 months
Change in bone structure
HRpQCT scans
Measured: baseline and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Bone DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Axellus
- Responsible party
- Sponsor
- Investigators
- Sofie Rønn, cand.med, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922804
- Sponsor's protocol ID
- K2vita
- Acronym
- K2vita
- Status last verified
- Oct 2016
- First submitted
- 6 Aug 2013
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ronn SH, Harslof T, Oei L, Pedersen SB, Langdahl BL. The effect of vitamin MK-7 on bone mineral density and microarchitecture in postmenopausal women with osteopenia, a 3-year randomized, placebo-controlled clinical trial. Osteoporos Int. 2021 Jan;32(1):185-191. doi: 10.1007/s00198-020-05638-z. Epub 2020 Oct 8.
PubMed 33030563
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of the Effect of MK-7 on Bone and Glucose Metabolism and Arterial Calcification
- ClinicalTrials.gov ID
- NCT01922804
- Acronym / sponsor ID
- K2vita / K2vita
- Conditions
- Metabolic Bone Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Axellus
- Study start
- Jul 2013
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 14 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.
The aims of the present study are to investigate the effect of vitamin K2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis.
Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.
Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.
Detailed description
Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world.
Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K2 vitamin | Experimental | Dietary Supplement: K2 vitaminK2 vitamin 375 microgram a day for 3 years |
| placebo | Placebo comparator | Dietary Supplement: Placebo1 tablet a day for 3 years |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- postmenopausal women
- 60-80 years
- osteopenia
Key exclusion criteria (12 listed)
- Calcium metabolic, thyroid, liver or kidney disease
- Diabetes
- Obesity
- Myocardial infarction or other arteriosclerotic events
- Angina pectoris
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 |
|---|---|---|
| K2 vitaminK2 vitamin tablet | Dietary supplement | K2 vitamin |
| PlaceboPlacebo tablets | Dietary supplement | placebo |
Primary outcome
p-undercarboxylated osteocalcin
Time frame: Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial.
5 secondary outcomes
Change in bone mineral density
Time frame: Assessed after 3, 6, 12, 24 and 36 months
Change in arterial stiffness, pulse wave velocity
Time frame: Measured at baseline and after 6 months
Change in insulin sensitivity
Time frame: Measured at baseline and after 1 and 12 months.
Change in bone turnover markers
Time frame: Measured at baseline, after 1, 3, 6, 12, 24 and 36 months
Change in bone structure
Time frame: baseline and month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Derived from this study: PubMed 33030563Ronn SH, Harslof T, Oei L, Pedersen SB, Langdahl BL. The effect of vitamin MK-7 on bone mineral density and microarchitecture in postmenopausal women with osteopenia, a 3-year randomized, placebo-controlled clinical trial. Osteoporos Int. 2021 Jan;32(1):185-191. doi: 10.1007/s00198-020-05638-z. Epub 2020 Oct 8.
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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.
Sofie Rønn, cand.med principal investigator
Aarhus University 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 K2 vitamin in people with Metabolic Bone Disorder, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
p-undercarboxylated osteocalcin (time frame: Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922804, which also lists 1 linked publication.
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 28 Oct 2016.