HealthyNCT00742768
Comparison of Absorption of Vitamin K2
A study testing Vitamin K2 in softgel and Vitamin K2 in Gelpell in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vitamin K2 in softgel and Vitamin K2 in Gelpell
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2008to Aug 2008
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women between 20 and 30 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 receiving corticoϊd treatment
- Subjects using oral anticoagulants
- Subject with (a history of) soy allergy
- Subjects using vitamin K containing multivitamins or vitamin K supplements
- Subjects with anaemia or subjects who recently donate blood.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Absorption of Vitamin K2 Human Study Gelpell
From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.
This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.
- Conditions
- Healthy
- Being tested
- Vitamin K2 in softgel, Vitamin K2 in Gelpell
- Keywords
- absorption, encapsulation, menaquinone, Bio-availability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2 in softgelDietary supplement
4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule
Vitamin K2 in GelpellDietary supplement
4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | softgel capsules Receives: Dietary Supplement: Vitamin K2 in softgel |
| 2 | Active comparator | Gelpell capsules Receives: Dietary Supplement: Vitamin K2 in Gelpell |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure.
Measured: 4 weeks
Secondary outcomes (1)
The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VitaK
- Responsible party
- Sponsor
- Investigators
- Cees Vermeer, PhD, Principal investigator, Maastricht University, VitaK BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742768
- Sponsor's protocol ID
- MEC 08-3-012
- Status last verified
- Mar 2009
- First submitted
- 27 Aug 2008
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Absorption of Vitamin K2 Human Study Gelpell
- ClinicalTrials.gov ID
- NCT00742768
- Acronym / sponsor ID
- MEC 08-3-012
- Conditions
- Healthy
- Keywords
- absorption, encapsulation, menaquinone, Bio-availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- VitaK
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 28 Aug 2008 (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.
From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.
This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Vitamin K2 in softgelsoftgel capsules |
| 2 | Active comparator | Dietary Supplement: Vitamin K2 in GelpellGelpell capsules |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women between 20 and 30 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 receiving corticoϊd treatment
- Subjects using oral anticoagulants
- Subject with (a history of) soy allergy
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 |
|---|---|---|
| Vitamin K2 in softgel4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule | Dietary supplement | 1 |
| Vitamin K2 in Gelpell4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule | Dietary supplement | 2 |
Primary outcome
The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure.
Time frame: 4 weeks
1 secondary outcome
The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study.
Time frame: 4 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 26 Apr 2018.
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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, VitaK BV
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 K2 in softgel and Vitamin K2 in Gelpell in people with Healthy, 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 26 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. 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 mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure. (time frame: 4 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 26 Apr 2018.