Bone HealthNCT01638182
Biocomparison Study
A study testing Vitamin K1-capsules and Vitamin K2-capsules in people with Bone Health and Vascular Health, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range. The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Health, Vascular Health
- What is being tested?
- Vitamin K1-capsules and Vitamin K2-capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2011to Sep 2011
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women, aged between 20-80 years
- Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2)
- Stable body weight (weight gain or loss < 3 kg in past 3 mo)
- Written consent to take part in the study
- Agreement to adhere to dietary restrictions required by the protocol
Who cannot join
- Abuse of drugs and/or alcohol
- Use of vitamin supplements containing vitamin K
- Pregnancy
- (a history of) metabolic or gastrointestinal diseases, e.g. hepatic or renal disorders, osteoporosis
- Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, cancer, cardiovascular disease
- Use of oral anticoagulants, drugs or hormones that influence bone metabolism
Show all 9Show fewer
- Corticoid treatment
- Subjects with anaemia or subjects who recently donated blood or plasma
- Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VitaK BV / Maastricht University Medicial Center
Maastricht
About this study
Official title: Comparison of Effects of Nutritional Doses Vitamin K1 and K2 on Carboxylation
The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range.
The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K.
Read the detailed description
Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K intake leads to improved bone and vascular health by increased carboxylation of vitamin K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC) and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after supplementing these vitamins at a dose not exceeding the RDA.
- Conditions
- Bone Health, Vascular Health
- Being tested
- Placebo, Vitamin K1-capsules, Vitamin K2-capsules
- Keywords
- phylloquinone,, menaquinone-7, vitamin K-status, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
27 participants received for three months 1 placebo capsule per day
Vitamin K1-capsulesDietary supplement
27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day
Vitamin K2-capsulesDietary supplement
27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.
| Study group | Role | What they receive |
|---|---|---|
| vitamin K1 capsules | Active comparator | 27 participants received for three months 1 vitamin K1-capsule per day containing 52 µg of K1 Receives: Dietary Supplement: Vitamin K1-capsules |
| Vitamin K2-capsules | Active comparator | 27 participants received for three months 1 vitamin K2-capsule per day containing 75 µg of MK-7. Receives: Dietary Supplement: Vitamin K2-capsules |
| Placebo capsules | Placebo comparator | 27 participants received for 3 months 1 placebo capsule per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
carboxylation of osteocalcin
The primary objective of the study is to compare the effects of K1 and MK-7 on circulating ucOC levels after supplementing these vitamins at a nutritional dose.
Measured: 12 weeks
Secondary outcomes (1)
carboxylation of matrix-gla protein
The secondary objective of the study is to compare the effects of K1 and MK-7 on circulating ucMGP, which is emerging as a biomarker of arterial calcification.
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 posted11 Jul 2012 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone HealthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 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, VitaK BV Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638182
- Sponsor's protocol ID
- 10-3-018
- Status last verified
- Jul 2012
- First submitted
- 9 Jul 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Nutritional Doses Vitamin K1 and K2 on Carboxylation
- ClinicalTrials.gov ID
- NCT01638182
- Acronym / sponsor ID
- 10-3-018
- Conditions
- Bone Health, Vascular Health
- Keywords
- phylloquinone,, menaquinone-7, vitamin K-status, efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Jul 2012 (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 effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range.
The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K.
Detailed description
Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K intake leads to improved bone and vascular health by increased carboxylation of vitamin K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC) and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after supplementing these vitamins at a dose not exceeding the RDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vitamin K1 capsules | Active comparator | Dietary Supplement: Vitamin K1-capsules27 participants received for three months 1 vitamin K1-capsule per day containing 52 µg of K1 |
| Vitamin K2-capsules | Active comparator | Dietary Supplement: Vitamin K2-capsules27 participants received for three months 1 vitamin K2-capsule per day containing 75 µg of MK-7. |
| Placebo capsules | Placebo comparator | Dietary Supplement: Placebo27 participants received for 3 months 1 placebo capsule per day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy men and women, aged between 20-80 years
- Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2)
- Stable body weight (weight gain or loss < 3 kg in past 3 mo)
- Written consent to take part in the study
- Agreement to adhere to dietary restrictions required by the protocol
Key exclusion criteria (9 listed)
- Abuse of drugs and/or alcohol
- Use of vitamin supplements containing vitamin K
- Pregnancy
- (a history of) metabolic or gastrointestinal diseases, e.g. hepatic or renal disorders, osteoporosis
- Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, cancer, cardiovascular disease
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 |
|---|---|---|
| Placebo27 participants received for three months 1 placebo capsule per day | Dietary supplement | Placebo capsules |
| Vitamin K1-capsules27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day | Dietary supplement | vitamin K1 capsules |
| Vitamin K2-capsules27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7. | Dietary supplement | Vitamin K2-capsules |
Primary outcome
carboxylation of osteocalcin
Time frame: 12 weeks
The primary objective of the study is to compare the effects of K1 and MK-7 on circulating ucOC levels after supplementing these vitamins at a nutritional dose.
1 secondary outcome
carboxylation of matrix-gla protein
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 11 Jul 2012.
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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
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-capsules and Vitamin K2-capsules in people with Bone Health and Vascular Health, 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 5 inclusion and 9 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 11 Jul 2012. 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?
carboxylation of osteocalcin (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 11 Jul 2012.