Carboxylation LevelNCT01194778
Comparison of Efficacy of Different Dosages Vitamin K2
A study testing vitamin K1 and vitamin K2 in people with Carboxylation Level and Vitamin K-dependent Proteins, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Carboxylation Level, Vitamin K-dependent Proteins
- What is being tested?
- vitamin K1 and vitamin K2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Aug 2010
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women between 40 and 60 years old
- Subjects of normal body weight and height according to BMI < 30
- Subjects of Caucasian race
- Subject has given written consent to take part in the study
Who cannot join
- Subjects with (a history of) metabolic or gastrointestinal disease
- Subjects presenting chronic degenerative and/or inflammatory disease
- Subjects presenting diabetes mellitus
- Abuse of drugs and/or alcohol
- Subjects receiving corticoϊd treatment including inhalators
- Subjects using oral anticoagulants
- Subjects using vitamin K containing multivitamins or vitamin K supplements
Trial locations and contacts
1 site in 1 country.
About this study
Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins). Therefore, this study was undertaken to study effects of different dosages of bacterial vitamin K2 on carboxylation of extrahepatic proteins.
Read the detailed description
Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Higher menaquinones not only have very long half-life times (over 3 days rather than 1 hour for vitamin K1); K2 vitamins are also transported to extra hepatic tissues such as bone and vessel wall whereas K1 is preferentially transported to the liver. Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins). This study describes a dose-response experiment for different dosages of bacterial K2 which are compared with one selected dose of K1 and placebo. The efficacy is concluded from the carboxylation of the bone Gla-protein osteocalcin and of the vascular Gla-protein matrix-Gla protein (MGP).
- Conditions
- Carboxylation Level, Vitamin K-dependent Proteins
- Being tested
- placebo, vitamin K1, vitamin K2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
1 placebo sachet per day containing only sucrose during 12 weeks
vitamin K1Dietary supplement
15 µg vitamin K1 per day during 12 weeks
vitamin K2Dietary supplement
15 µg vitamin K2 per day during 12 weeks
vitamin K2Dietary supplement
30 µg vitamin K2 per day during 12 weeks
vitamin K2Dietary supplement
45 µg vitamin K2 per day during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | The participants of the placebo group will receive daily 1 placebo sachet containing only sucrose Receives: Dietary Supplement: placebo |
| vitamin K1 | Active comparator | The participants of this group will receive daily 1 sachet containing 15 µg vitamin K1. Receives: Dietary Supplement: vitamin K1 |
| vitamin K2 - 15 µg | Active comparator | The participants of this group will receive daily 1 sachet containing 15 µg vitamin K2 Receives: Dietary Supplement: vitamin K2 |
| vitamin K2 - 30 µg | Active comparator | The participants of this group will receive daily 1 sachet containing 30 µg vitamin K2 Receives: Dietary Supplement: vitamin K2 |
| vitamin K2 - 45 µg | Active comparator | The participants of this group will receive daily 1 sachet containing 45 µg vitamin K2. Receives: Dietary Supplement: vitamin K2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of the circulating biochemical markers matrix-Gla protein and osteocalcin. Both proteins will be measured in their active form (carboxylated form) and their inactive form (undercarboxylated form).
The main purpose of the study is to investigate the efficacy of different dosages bacterial vitamin K2 and vitamin K1 on carboxylation degree of the vitamin K-dependent proteins osteocalcin and matrix-gla protein.
Measured: 12 weeks
Secondary outcomes (1)
the number or type of bacteria in the stool
The second purpose of the study is to monitor whether the increased vitamin K intake will change the composition of the intestinal flora, as measured from the collected stools. Vitamin K, notably K2 is produced by a number of colonic bacteria and our principal is interested to learn whether the intake of extra vitamin K will affect the number or type of bacteria in the stool.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startOct 2009
- Primary completionFeb 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carboxylation LevelStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Cees Vermeer, PhD, Principal investigator, VitaK BV Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194778
- Sponsor's protocol ID
- 08-3-078
- Status last verified
- Sep 2010
- First submitted
- 5 Aug 2010
- Last updated
- 3 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Different Dosages Vitamin K2
- ClinicalTrials.gov ID
- NCT01194778
- Acronym / sponsor ID
- 08-3-078
- Conditions
- Carboxylation Level, Vitamin K-dependent Proteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Sep 2010 (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.
Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins). Therefore, this study was undertaken to study effects of different dosages of bacterial vitamin K2 on carboxylation of extrahepatic proteins.
Detailed description
Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Higher menaquinones not only have very long half-life times (over 3 days rather than 1 hour for vitamin K1); K2 vitamins are also transported to extra hepatic tissues such as bone and vessel wall whereas K1 is preferentially transported to the liver. Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins). This study describes a dose-response experiment for different dosages of bacterial K2 which are compared with one selected dose of K1 and placebo. The efficacy is concluded from the carboxylation of the bone Gla-protein osteocalcin and of the vascular Gla-protein matrix-Gla protein (MGP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: placeboThe participants of the placebo group will receive daily 1 placebo sachet containing only sucrose |
| vitamin K1 | Active comparator | Dietary Supplement: vitamin K1The participants of this group will receive daily 1 sachet containing 15 µg vitamin K1. |
| vitamin K2 - 15 µg | Active comparator | Dietary Supplement: vitamin K2The participants of this group will receive daily 1 sachet containing 15 µg vitamin K2 |
| vitamin K2 - 30 µg | Active comparator | Dietary Supplement: vitamin K2The participants of this group will receive daily 1 sachet containing 30 µg vitamin K2 |
| vitamin K2 - 45 µg | Active comparator | Dietary Supplement: vitamin K2The participants of this group will receive daily 1 sachet containing 45 µg vitamin K2. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women between 40 and 60 years old
- Subjects of normal body weight and height according to BMI < 30
- Subjects of Caucasian race
- Subject has given written consent to take part in the study
Key exclusion criteria (7 listed)
- Subjects with (a history of) metabolic or gastrointestinal disease
- Subjects presenting chronic degenerative and/or inflammatory disease
- Subjects presenting diabetes mellitus
- Abuse of drugs and/or alcohol
- Subjects receiving corticoϊd treatment including inhalators
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 |
|---|---|---|
| placebo1 placebo sachet per day containing only sucrose during 12 weeks | Dietary supplement | placebo |
| vitamin K115 µg vitamin K1 per day during 12 weeks | Dietary supplement | vitamin K1 |
| vitamin K215 µg vitamin K2 per day during 12 weeks | Dietary supplement | vitamin K2 - 15 µg |
| vitamin K230 µg vitamin K2 per day during 12 weeks | Dietary supplement | vitamin K2 - 30 µg |
| vitamin K245 µg vitamin K2 per day during 12 weeks | Dietary supplement | vitamin K2 - 45 µg |
Primary outcome
The concentration of the circulating biochemical markers matrix-Gla protein and osteocalcin. Both proteins will be measured in their active form (carboxylated form) and their inactive form (undercarboxylated form).
Time frame: 12 weeks
The main purpose of the study is to investigate the efficacy of different dosages bacterial vitamin K2 and vitamin K1 on carboxylation degree of the vitamin K-dependent proteins osteocalcin and matrix-gla protein.
1 secondary outcome
the number or type of bacteria in the stool
Time frame: 12 weeks
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 3 Sep 2010.
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.
Cees Vermeer, PhD principal investigator
VitaK BV Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin K1 and vitamin K2 in people with Carboxylation Level and Vitamin K-dependent Proteins, run by Maastricht University Medical Center at 1 site in Netherlands.
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 7 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 3 Sep 2010. 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 Netherlands. 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?
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?
The concentration of the circulating biochemical markers matrix-Gla protein and osteocalcin. Both proteins will be measured in their active form (carboxylated form) and their inactive form (undercarboxylated form). (time frame: 12 weeks). 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 3 Sep 2010.