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CKD 5D, HemodialysisPhase 3NCT01407601

Vitamin K2 Supplementation to Activate Matrix Gla Protein (MGP) as Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients

A Phase 3 study testing daily supplementation of MK-7 over 6 weeks in people with CKD 5D, Hemodialysis, run by RWTH Aachen University at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Vascular calcification (VC) is a predictor of cardiovascular morbidity and mortality. Hemodialysis (HD) patients suffer from severe vascular calcifications. Matrix Gla protein (MGP) is a central calcification inhibitor of the arterial wall and its activity depends on vitamin K-dependent γ-glutamate carboxylation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CKD 5D, Hemodialysis
What is being tested?
daily supplementation of MK-7 over 6 weeks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
3 sitesGermany
Study dates
Jan 2008to Jul 2009
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

  • > 18 years of age
  • minimum of 3 months of hemodialysis
  • written consent

Who cannot join

  • chronic or acute bowel disease
  • soy bean allergy
  • active Vitamin K Supplementation
  • oral anticoagulation with vitamin K Antagonists (coumarins)
  • systemic therapy using steroids
  • positive history for thrombosis or embolism
  • pregnancy

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • KfH Dialysis Unit Aachen

    Aachen, North Rhine-Westphalia, 52074

  • University Hospital of the RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Dialysis Unit Erkelenz

    Erkelenz, North Rhine-Westphalia, 41812

Other trials in Germany

About this study

Official title: Food Supplementation With Vitamin K2 to Activate MGP as an Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients

Vascular calcification (VC) is a predictor of cardiovascular morbidity and mortality. Hemodialysis (HD) patients suffer from severe vascular calcifications. Matrix Gla protein (MGP) is a central calcification inhibitor of the arterial wall and its activity depends on vitamin K-dependent γ-glutamate carboxylation. Noncarboxylated MGP, formed as a result of vitamin K deficiency, is associated with cardiovascular disease. Recent studies pointed towards poor vitamin K status in HD patients. We therefore aim to investigate whether daily vitamin K2 (MK-7) supplementation improves the bioactivity of vitamin K-dependent proteins in HD patients as assessed by circulating dephospho-noncarboxylated MGP (dp-ucMGP), noncarboxylated osteocalcin (ucOC) and noncarboxylated prothrombin (ucFII; PIVKA-II).

Being tested
daily supplementation of MK-7 over 6 weeks
Keywords
vitamin K, MK-7, Hemodialysis, vascular calcification, Matrix Gla protein, Osteocalcin
Medical subject headings
Vascular Calcification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • daily supplementation of MK-7 over 6 weeksDietary supplement

    once daily intake of MK-7 prior to dialysis over 6 weeks

Study groups in NCT01407601
Study groupRoleWhat they receive
45 µg MK-7Experimental45 µg MK-7 daily over 6 weeks
Receives: Dietary Supplement: daily supplementation of MK-7 over 6 weeks
135 µg MK-7Experimental135 µg MK-7 daily over 6 weeks
Receives: Dietary Supplement: daily supplementation of MK-7 over 6 weeks
360 µg MK-7Experimental360 µg MK-7 daily over 6 weeks
Receives: Dietary Supplement: daily supplementation of MK-7 over 6 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of plasma levels of noncarboxylated MGP

    Noncarboxylated MGP levels [pmol/L] will be determined from plasma samples by a non-commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.

    Measured: after 6 weeks of supplementation

  2. Reduction of plasma levels of noncarboxylated osteocalcin

    Noncarboxylated osteocalcin levels [ng/ml] will be determined from plasma samples by a commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.

    Measured: after 6 weeks of supplementation

  3. Reduction of plasma levels of inactive prothrombin (PIVKA-II)

    PIVKA-II levels [ng/ml] will be determined from plasma samples by a commercial ELISA. Plasma levels at the end of the six-week treatment period will be compared to baseline levels.

    Measured: after 6 weeks of supplementation

Secondary outcomes (2)

  1. increase of plasma levels of carboxylated MGP

    Carboxylated MGP levels [pmol/L] will be determined from plasma samples by a non-commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.

    Measured: after 6 weeks of supplementation

  2. increase of plasma levels of carboxylated osteocalcin

    Carboxylated MGP levels [ng/ml] will be determined from plasma samples by a commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.

    Measured: after 6 weeks of supplementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2011 (estimated)
  2. Study startJan 2008
  3. Primary completionMay 2008
  4. Study completionJul 2009

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01407601
Sponsor's protocol ID
EK 111/07
Status last verified
Aug 2011
First submitted
29 Jul 2011
Last updated
2 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • Westenfeld R, Krueger T, Schlieper G, Cranenburg EC, Magdeleyns EJ, Heidenreich S, Holzmann S, Vermeer C, Jahnen-Dechent W, Ketteler M, Floege J, Schurgers LJ. Effect of vitamin K2 supplementation on functional vitamin K deficiency in hemodialysis patients: a randomized trial. Am J Kidney Dis. 2012 Feb;59(2):186-95. doi: 10.1053/j.ajkd.2011.10.041. Epub 2011 Dec 9.

    PubMed 22169620

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing daily supplementation of MK-7 over 6 weeks in people with CKD 5D, Hemodialysis, run by RWTH Aachen University at 3 sites in Germany.

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 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 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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 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?

Reduction of plasma levels of noncarboxylated MGP (time frame: after 6 weeks of supplementation). The study lists 3 primary outcomes in all. 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 NCT01407601, 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 2 Aug 2011.

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