BioequivalenceNCT01638143
Bio-equivalence Study
A study testing MenaQ7 M-1500 capsules, Gnosis P-1000 capsules and Gnosis M-1500 capsules in people with Bioequivalence and Bioavailability, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, Bioavailability
- What is being tested?
- MenaQ7 M-1500 capsules, Gnosis P-1000 capsules and Gnosis M-1500 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Aug 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women, aged between 20 and 40 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
- Soy allergy
- Pregnancy
- a history of) metabolic or gastrointestinal diseases including hepatic disorders
- Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure
Show all 10Show fewer
- Use of oral anticoagulants
- 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 Medical Center
Maastricht
About this study
Official title: Comparison of Bioavailability of Three Different Vitamin K2 Formulations
The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.
Read the detailed description
Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.
- Conditions
- Bioequivalence, Bioavailability
- Being tested
- MenaQ7 M-1500 capsules, Gnosis P-1000 capsules, Gnosis M-1500 capsules
- Keywords
- vitamin K2, menaquinone-7, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenaQ7 M-1500 capsulesDietary supplement
The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):
- MenaQ7 M-1500 capsule
- Gnosis P-1000 capsule
- Gnosis M-1500 capsule
Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.
Gnosis P-1000 capsulesDietary supplement
The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):
- MenaQ7 M-1500 capsule
- Gnosis P-1000 capsule
- Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.
Gnosis M-1500 capsulesDietary supplement
The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):
- MenaQ7 M-1500 capsule
- Gnosis P-1000 capsule
- Gnosis M-1500 capsule
Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gnosis P-1000 capsules | Active comparator | MK-7 capsules containing 75 µg of MK-7 (source: Gnosis, Italy). Receives: Dietary Supplement: Gnosis P-1000 capsules |
| Gnosis M1500 capsules | Active comparator | MK-7 capsules containing 75 µg of MK-7 (source Gnosis, Italy). Receives: Dietary Supplement: Gnosis M-1500 capsules |
| MenaQ7 M-1500 capsules | Active comparator | MK-7 capsules containing 75 µg of MK-7 (source: Nattopharma, Norway) Receives: Dietary Supplement: MenaQ7 M-1500 capsules; Dietary Supplement: Gnosis P-1000 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
MK-7 absorption profiles
The purpose of this study is to compare the MK-7 absorption profiles after intake of three different vitamin K2 (MK-7) products that are already on the market. The main study parameter is therefore the calculated AUC value from the individual MK-7 absorption profiles.
Measured: 9 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 startNov 2010
- Primary completionJan 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT01638143
- Sponsor's protocol ID
- 10-3-017
- 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 Bioavailability of Three Different Vitamin K2 Formulations
- ClinicalTrials.gov ID
- NCT01638143
- Acronym / sponsor ID
- 10-3-017
- Conditions
- Bioequivalence, Bioavailability
- Keywords
- vitamin K2, menaquinone-7, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 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 primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.
Detailed description
Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gnosis P-1000 capsules | Active comparator | Dietary Supplement: Gnosis P-1000 capsulesMK-7 capsules containing 75 µg of MK-7 (source: Gnosis, Italy). |
| Gnosis M1500 capsules | Active comparator | Dietary Supplement: Gnosis M-1500 capsulesMK-7 capsules containing 75 µg of MK-7 (source Gnosis, Italy). |
| MenaQ7 M-1500 capsules | Active comparator | Dietary Supplement: MenaQ7 M-1500 capsules, Dietary Supplement: Gnosis P-1000 capsulesMK-7 capsules containing 75 µg of MK-7 (source: Nattopharma, Norway) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men and women, aged between 20 and 40 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 (10 listed)
- Abuse of drugs and/or alcohol
- Use of vitamin supplements containing vitamin K
- Soy allergy
- Pregnancy
- a history of) metabolic or gastrointestinal diseases including hepatic disorders
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 |
|---|---|---|
| MenaQ7 M-1500 capsulesThe study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): * MenaQ7 M-1500 capsule * Gnosis P-1000 capsule * Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks. | Dietary supplement | MenaQ7 M-1500 capsules |
| Gnosis P-1000 capsulesThe study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): * MenaQ7 M-1500 capsule * Gnosis P-1000 capsule * Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks. | Dietary supplement | Gnosis P-1000 capsules, MenaQ7 M-1500 capsules |
| Gnosis M-1500 capsulesThe study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): * MenaQ7 M-1500 capsule * Gnosis P-1000 capsule * Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks. | Dietary supplement | Gnosis M1500 capsules |
Primary outcome
MK-7 absorption profiles
Time frame: 9 weeks
The purpose of this study is to compare the MK-7 absorption profiles after intake of three different vitamin K2 (MK-7) products that are already on the market. The main study parameter is therefore the calculated AUC value from the individual MK-7 absorption profiles.
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 MenaQ7 M-1500 capsules, Gnosis P-1000 capsules and Gnosis M-1500 capsules in people with Bioequivalence and Bioavailability, 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 10 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. 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?
MK-7 absorption profiles (time frame: 9 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.