Arterial StiffnessPhase 2KINGNCT02517580
Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)
A Phase 2 study testing Vitamin K2 (MK7) in people with Arterial Stiffness and Vitamin K2 Deficiency, run by Lebanese American University at 1 site in Lebanon.
Trial summary
This study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Stiffness, Vitamin K2 Deficiency
- What is being tested?
- Vitamin K2 (MK7)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- Mar 2015to May 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Functional renal graft
- Stable renal function for at least 3 months prior to enrollment
Who cannot join
- History of thrombotic events
- Diagnosed coagulopathy
- Cardiovascular event in the past month prior to enrollment
- Current or planned pregnancy
- Lactation
- Soy allergy
Show all 9Show fewer
- Concomitant or recent (past 6 months) use of supplements that contain vitamin K
- Warfarin treatment
- Known intestinal malabsorption or hypomotility syndromes
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
Lebanese American University Medical Center - Rizk Hospital
El Achrafiyé, Beirut
About this study
Official title: Vitamin K2 Supplementation and Effect on Arterial Stiffness Progression in the Renal Transplant Population
This study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients.
- Conditions
- Arterial Stiffness, Vitamin K2 Deficiency
- Being tested
- Vitamin K2 (MK7)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2 (MK7)Dietary supplement
Also called MenaQ7
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K2 (MK7) | Experimental | Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks Receives: Dietary Supplement: Vitamin K2 (MK7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks
Measured: 8 weeks
Secondary outcomes (3)
Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
Measured: 8 weeks
Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
Measured: 8 weeks
Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial StiffnessStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Collaborators
- Omicron Pharmaceuticals
- Responsible party
- Principal investigator, Sola Aoun Bahous, M.D. Ph.D., Lebanese American University
- Investigators
- Sola Aoun Bahous, M.D. Ph.D., Principal investigator, Lebanese American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517580
- Sponsor's protocol ID
- MK7-002
- Acronym
- KING
- Status last verified
- Aug 2017
- First submitted
- 5 Aug 2015
- Last updated
- 9 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mansour AG, Hariri E, Daaboul Y, Korjian S, El Alam A, Protogerou AD, Kilany H, Karam A, Stephan A, Bahous SA. Vitamin K2 supplementation and arterial stiffness among renal transplant recipients-a single-arm, single-center clinical trial. J Am Soc Hypertens. 2017 Sep;11(9):589-597. doi: 10.1016/j.jash.2017.07.001. Epub 2017 Jul 13.
PubMed 28756183
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K2 Supplementation and Effect on Arterial Stiffness Progression in the Renal Transplant Population
- ClinicalTrials.gov ID
- NCT02517580
- Acronym / sponsor ID
- KING / MK7-002
- Conditions
- Arterial Stiffness, Vitamin K2 Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Collaborators
- Omicron Pharmaceuticals
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Posted 9 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin K2 (MK7) | Experimental | Dietary Supplement: Vitamin K2 (MK7)Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Functional renal graft
- Stable renal function for at least 3 months prior to enrollment
Key exclusion criteria (9 listed)
- History of thrombotic events
- Diagnosed coagulopathy
- Cardiovascular event in the past month prior to enrollment
- Current or planned pregnancy
- Lactation
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 (MK7)Also: MenaQ7 | Dietary supplement | Vitamin K2 (MK7) |
Primary outcome
Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks
Time frame: 8 weeks
3 secondary outcomes
Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
Time frame: 8 weeks
Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
Time frame: 8 weeks
Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28756183Mansour AG, Hariri E, Daaboul Y, Korjian S, El Alam A, Protogerou AD, Kilany H, Karam A, Stephan A, Bahous SA. Vitamin K2 supplementation and arterial stiffness among renal transplant recipients-a single-arm, single-center clinical trial. J Am Soc Hypertens. 2017 Sep;11(9):589-597. doi: 10.1016/j.jash.2017.07.001. Epub 2017 Jul 13.
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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.
Sola Aoun Bahous, M.D. Ph.D. principal investigator
Lebanese American University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin K2 (MK7) in people with Arterial Stiffness and Vitamin K2 Deficiency, run by Lebanese American University at 1 site in Lebanon.
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 2 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 9 Feb 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 Lebanon. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks (time frame: 8 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 NCT02517580, which also lists 1 linked publication.
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 9 Feb 2018.