Vitamin K-statusNCT00483431
Dose-finding Study for Vitamin K2 in Human Volunteers
A study testing MK7 in people with Vitamin K-status, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins, Menaquinone-7 (MK7) has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin K-status
- What is being tested?
- MK7
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2007to Oct 2007
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female adults between 18 and 45 years of age.
- Subjects of normal body weight and height according to BMI < 30
- Subject has given written consent to take part in the study
Who cannot join
- Subjects with (a history of) metabolic or gastrointestinal disease
- Subject with (a history of) soy allergy
- Subjects using vitamin supplements containing vitamin K
- Subjects presenting chronic inflammatory diseases
- Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- Subjects receiving corticoϊd treatment
- Subjects using oral anticoagulants
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VitaK BV / University of Maastricht
Maastricht, PO Box 616, 6200 MD
About this study
Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins, Menaquinone-7 (MK7) has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains which dosage of MK7 leads to optimal carboxylation levels of these proteins.
The primary objective of this double-blind randomized intervention study is to establish the optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.
Read the detailed description
This study is a double-blind randomized intervention study. In total 42 healthy volunteers (men and women) between 18 and 45 years will be recruited among the Maastricht University community (coworkers/students) and randomized into one of the following groups:
Placebo, 10 mcg MK7, 20 mcg MK7, 45 mcg MK7, 90 mcg MK7, 180 mcg MK7, 360 mcg MK7.
Each group will consist of 6 volunteers with approximately equal numbers of men and women (3 men / 3 women). A double-blind design of the study is chosen to avoid the occurrence of bias during the study. The randomization procedure will be performed by an investigator who is not involved in the coordination of the study and will generate specific randomization codes for each subject. After randomization, the volunteers consume the indicated amount of capsules once daily with either breakfast of dinner during a period of 12 weeks.
During the first week, blood samples of the volunteers will be collected at day 0, 1, 3 and 7 to study immediate effects on carboxylation of OC and MGP. After the first week, blood samples will be drawn every first day of week 2, 4, 6, 8, 10, and 12.
- Conditions
- Vitamin K-status
- Being tested
- Placebo, MK7
- Keywords
- vitamin K2, dosis-response, osteocalcin, matrix-gla protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
MK7Dietary supplement
Also called Menaquinone-7
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | MK7 dosage 0 mcg, 4 capsules, orally, daily for 12 weeks. Receives: Dietary Supplement: Placebo |
| MK7_10 | Active comparator | MK7 dosage 10 mcg, 1 capsule of 10 mcg and 3 placebo-capsules, orally, daily for 12 weeks. Receives: Dietary Supplement: MK7 |
| MK7_20 | Active comparator | MK7 dosage 20 mcg, 2 capsules of 10 mcg and 2 placebo-capsules, orally, daily for 12 weeks. Receives: Dietary Supplement: MK7 |
| MK7_45 | Active comparator | MK7 dosage 45 mcg, 1 capsules of 45 mcg and 3 placebo-capsules, orally, daily for 12 weeks. Receives: Dietary Supplement: MK7 |
| MK7_90 | Active comparator | MK7 dosage 90 mcg, 2 capsules of 45 mcg and 2 placebo-capsules, orally, daily for 12 weeks. Receives: Dietary Supplement: MK7 |
| MK7_180 | Active comparator | MK7 dosage 180 mcg, 4 capsules of 45 mcg, orally, daily for 12 weeks. Receives: Dietary Supplement: MK7 |
| MK7_360 | Active comparator | MK7 dosage 360 mcg, 1 capsule of 360 mcg and 3 placebo-capsules, orally, daily for 12 weeks. Receives: Dietary Supplement: MK7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
undercarboxylated osteocalcin (ucOC)
UcOC will be assessed by making use of a sandwich ELISA (in ng/ml)
Measured: 12 weeks
Secondary outcomes (2)
carboxylated osteocalcin (cOC)
cOC will be assessed by making use of a sandwich ELISA (in ng/ml)
Measured: 12 weeks
undercarboxylated matrix-gla protein (ucMGP)
ucMGP will be assessed by making use of a sandwich ELISA (in pM)
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 posted7 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin K-statusStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cees Vermeer, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483431
- Sponsor's protocol ID
- MEC 07-3-014
- Status last verified
- Mar 2009
- First submitted
- 6 Jun 2007
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Theuwissen E, Cranenburg EC, Knapen MH, Magdeleyns EJ, Teunissen KJ, Schurgers LJ, Smit E, Vermeer C. Low-dose menaquinone-7 supplementation improved extra-hepatic vitamin K status, but had no effect on thrombin generation in healthy subjects. Br J Nutr. 2012 Nov 14;108(9):1652-7. doi: 10.1017/S0007114511007185. Epub 2012 Jan 31.
PubMed 22289649Knapen MH, Schurgers LJ, Shearer MJ, Newman P, Theuwissen E, Vermeer C. Association of vitamin K status with adiponectin and body composition in healthy subjects: uncarboxylated osteocalcin is not associated with fat mass and body weight. Br J Nutr. 2012 Sep 28;108(6):1017-24. doi: 10.1017/S000711451100626X. Epub 2011 Dec 5.
PubMed 22136751
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-finding Study for Vitamin K2 in Human Volunteers
- ClinicalTrials.gov ID
- NCT00483431
- Acronym / sponsor ID
- MEC 07-3-014
- Conditions
- Vitamin K-status
- Keywords
- vitamin K2, dosis-response, osteocalcin, matrix-gla protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 7 Jun 2007 (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.
Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins, Menaquinone-7 (MK7) has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains which dosage of MK7 leads to optimal carboxylation levels of these proteins.
The primary objective of this double-blind randomized intervention study is to establish the optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.
Detailed description
This study is a double-blind randomized intervention study. In total 42 healthy volunteers (men and women) between 18 and 45 years will be recruited among the Maastricht University community (coworkers/students) and randomized into one of the following groups:
Placebo, 10 mcg MK7, 20 mcg MK7, 45 mcg MK7, 90 mcg MK7, 180 mcg MK7, 360 mcg MK7.
Each group will consist of 6 volunteers with approximately equal numbers of men and women (3 men / 3 women). A double-blind design of the study is chosen to avoid the occurrence of bias during the study. The randomization procedure will be performed by an investigator who is not involved in the coordination of the study and will generate specific randomization codes for each subject. After randomization, the volunteers consume the indicated amount of capsules once daily with either breakfast of dinner during a period of 12 weeks.
During the first week, blood samples of the volunteers will be collected at day 0, 1, 3 and 7 to study immediate effects on carboxylation of OC and MGP. After the first week, blood samples will be drawn every first day of week 2, 4, 6, 8, 10, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Dietary Supplement: PlaceboMK7 dosage 0 mcg, 4 capsules, orally, daily for 12 weeks. |
| MK7_10 | Active comparator | Dietary Supplement: MK7MK7 dosage 10 mcg, 1 capsule of 10 mcg and 3 placebo-capsules, orally, daily for 12 weeks. |
| MK7_20 | Active comparator | Dietary Supplement: MK7MK7 dosage 20 mcg, 2 capsules of 10 mcg and 2 placebo-capsules, orally, daily for 12 weeks. |
| MK7_45 | Active comparator | Dietary Supplement: MK7MK7 dosage 45 mcg, 1 capsules of 45 mcg and 3 placebo-capsules, orally, daily for 12 weeks. |
| MK7_90 | Active comparator | Dietary Supplement: MK7MK7 dosage 90 mcg, 2 capsules of 45 mcg and 2 placebo-capsules, orally, daily for 12 weeks. |
| MK7_180 | Active comparator | Dietary Supplement: MK7MK7 dosage 180 mcg, 4 capsules of 45 mcg, orally, daily for 12 weeks. |
| MK7_360 | Active comparator | Dietary Supplement: MK7MK7 dosage 360 mcg, 1 capsule of 360 mcg and 3 placebo-capsules, orally, daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female adults between 18 and 45 years of age.
- Subjects of normal body weight and height according to BMI < 30
- 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
- Subject with (a history of) soy allergy
- Subjects using vitamin supplements containing vitamin K
- Subjects presenting chronic inflammatory diseases
- Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
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 |
|---|---|---|
| Placebo | Dietary supplement | PLACEBO |
| MK7Also: Menaquinone-7 | Dietary supplement | MK7_10, MK7_180, MK7_20, MK7_360, MK7_45, MK7_90 |
Primary outcome
undercarboxylated osteocalcin (ucOC)
Time frame: 12 weeks
UcOC will be assessed by making use of a sandwich ELISA (in ng/ml)
2 secondary outcomes
carboxylated osteocalcin (cOC)
Time frame: 12 weeks
undercarboxylated matrix-gla protein (ucMGP)
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 27 Apr 2018.
- Derived from this study: PubMed 22289649Theuwissen E, Cranenburg EC, Knapen MH, Magdeleyns EJ, Teunissen KJ, Schurgers LJ, Smit E, Vermeer C. Low-dose menaquinone-7 supplementation improved extra-hepatic vitamin K status, but had no effect on thrombin generation in healthy subjects. Br J Nutr. 2012 Nov 14;108(9):1652-7. doi: 10.1017/S0007114511007185. Epub 2012 Jan 31.
- Derived from this study: PubMed 22136751Knapen MH, Schurgers LJ, Shearer MJ, Newman P, Theuwissen E, Vermeer C. Association of vitamin K status with adiponectin and body composition in healthy subjects: uncarboxylated osteocalcin is not associated with fat mass and body weight. Br J Nutr. 2012 Sep 28;108(6):1017-24. doi: 10.1017/S000711451100626X. Epub 2011 Dec 5.
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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.
Cees Vermeer, PhD principal investigator
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 MK7 in people with Vitamin K-status, 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 3 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 27 Apr 2018. 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?
undercarboxylated osteocalcin (ucOC) (time frame: 12 weeks). 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 NCT00483431, which also lists 2 linked publications.
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 27 Apr 2018.