Vascular CalcificationPhase 3NCT01675206
Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients
A Phase 3 study testing Vitamin K2 supplementation in people with Vascular Calcification, run by Rogier Caluwe.
Trial summary
This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Calcification
- What is being tested?
- Vitamin K2 supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Apr 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 year
- signed informed consent
- end stage renal disease treated with chronic hemodialysis at least three times a week
Who cannot join
- coumarin treatment
- known intestinal malabsorption
- inability to take oral medication
- medical conditions with a considerable probability for death within 2 months
About this study
Official title: Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients
This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.
Read the detailed description
During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost 2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).
It is widely recognized that patients with renal insufficiency treated with hemodialysis are prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).
Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients against accelerated vascular calcification by enhancing the gamma-carboxylation process of MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be defined
- Conditions
- Vascular Calcification
- Being tested
- Vitamin K2 supplementation
- Keywords
- Vascular calcification, Hemodialysis, Matrix Gla Protein, Vitamin K2
- Medical subject headings
- Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2 supplementationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 360 µg Vit K2 | Active comparator | Administration of 360 µg of Vitamin K2 thrice weekly Receives: Dietary Supplement: Vitamin K2 supplementation |
| 720 µg Vit K2 | Active comparator | Administration of 720 µg of Vitamin K2 thrice weekly Receives: Dietary Supplement: Vitamin K2 supplementation |
| 1080 µg Vit K2 | Active comparator | Administration of 1080 µg of Vitamin K2 thrice weekly Receives: Dietary Supplement: Vitamin K2 supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation
this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP
Measured: 8 weeks
Secondary outcomes (1)
Assessment of adverse reactions associated with Vitamin K2 intake
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 posted29 Aug 2012 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular CalcificationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rogier Caluwe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rogier Caluwe, Onze Lieve Vrouw Hospital
- Investigators
- Rogier Caluwé, MD, Principal investigator, OLV Hospital Aalst BelgiumBruno Van Vlem, MD, PhD, Study chair, OLV Hospital Aalst BelgiumAn Devriese, MD, PhD, Study chair, AZ St.-Jan Brugge BelgiumStefaan Vandecasteele, MD, PhD, Study chair, AZ St.-Jan Brugge Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675206
- Sponsor's protocol ID
- 2010/066
- Status last verified
- Aug 2012
- First submitted
- 22 Aug 2012
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01675206
- Acronym / sponsor ID
- 2010/066
- Conditions
- Vascular Calcification
- Keywords
- Vascular calcification, Hemodialysis, Matrix Gla Protein, Vitamin K2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Rogier CaluweUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Aug 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.
This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.
Detailed description
During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost 2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).
It is widely recognized that patients with renal insufficiency treated with hemodialysis are prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).
Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients against accelerated vascular calcification by enhancing the gamma-carboxylation process of MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be defined
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 360 µg Vit K2 | Active comparator | Dietary Supplement: Vitamin K2 supplementationAdministration of 360 µg of Vitamin K2 thrice weekly |
| 720 µg Vit K2 | Active comparator | Dietary Supplement: Vitamin K2 supplementationAdministration of 720 µg of Vitamin K2 thrice weekly |
| 1080 µg Vit K2 | Active comparator | Dietary Supplement: Vitamin K2 supplementationAdministration of 1080 µg of Vitamin K2 thrice weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 year
- signed informed consent
- end stage renal disease treated with chronic hemodialysis at least three times a week
Key exclusion criteria (4 listed)
- coumarin treatment
- known intestinal malabsorption
- inability to take oral medication
- medical conditions with a considerable probability for death within 2 months
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 supplementation | Dietary supplement | 1080 µg Vit K2, 360 µg Vit K2, 720 µg Vit K2 |
Primary outcome
percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation
Time frame: 8 weeks
this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP
1 secondary outcome
Assessment of adverse reactions associated with Vitamin K2 intake
Time frame: 8 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 29 Aug 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.
Rogier Caluwé, MD principal investigator
OLV Hospital Aalst Belgium
Bruno Van Vlem, MD, PhD study chair
OLV Hospital Aalst Belgium
An Devriese, MD, PhD study chair
AZ St.-Jan Brugge Belgium
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin K2 supplementation in people with Vascular Calcification, run by Rogier Caluwe.
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 4 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 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation (time frame: 8 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 29 Aug 2012.