Vitamin K DeficiencyNCT05360342
Incorporation of Vitamin K Into Uremic Lipoproteins
A study testing Vitamin K supplement in people with Vitamin K Deficiency, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Chronic kidney disease (CKD) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. CKD patients exhibit a functional vitamin K deficiency. Calcification can be prevented by vitamin K intake. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin K Deficiency
- What is being tested?
- Vitamin K supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 31 Mar 2020to 15 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Controls: adequate kidney function (GFR > 60 ml/min/1,73m2)
- Patients: chronic haemodialysis
- Written consent to take part in the study
Who cannot join
- Intake of vitamin K antagonists
- gastro-intestinal diseases interfering with vitamin K intake
- profound anemia with an Hb < 10 g/dl
- judicial or official commitment to an institution
- pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Chronic kidney disease (CKD) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. CKD patients exhibit a functional vitamin K deficiency. Calcification can be prevented by vitamin K intake. The aim of this study is to investigate the cause for the vitamin K deficiency beyond a diminished dietary vitamin K uptake.
Read the detailed description
This study is a monocentric, 1-armed interventional trial. Participants will be recruited at the University Hospital of the RWTH Aachen.
We will analyse serially collected serum from 10 dialysis patients, after ingestion of a single vitamin K supplement, compared to healthy controls. Lipoprotein fractions will be isolated and the corresponding vitamin K contents will be measured by chromatography.
The vitamin K supplement contains 3 subforms of vitamin K: vitamin K1 (1000µg), menaquinone-4 (1000µg) and menaquinone-7 (200µg).
- Conditions
- Vitamin K Deficiency
- Being tested
- Vitamin K supplement
- Medical subject headings
- Vitamin K Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K supplementDrug
Also called High dose vitamin K1 and K2 supplement
Single dose of vitamin K supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K supplement | Experimental | Administration of a single dose vitamin K Receives: Drug: Vitamin K supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin K content in lipoproteins
Assessment of vitamin K incorporation into lipoproteins
Measured: 1 year
Secondary outcomes (1)
PIVKA-II levels
PIVKA-II in serum as assessed by ELISA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start31 Mar 2020
- Primary completion15 Jul 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin K DeficiencyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jürgen Floege, RWTH Aachen University
- Investigators
- Jürgen Floege, MD, Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360342
- Sponsor's protocol ID
- RWTH Aachen University
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporation of Vitamin K Into Uremic Lipoproteins
- ClinicalTrials.gov ID
- NCT05360342
- Acronym / sponsor ID
- RWTH Aachen University
- Conditions
- Vitamin K Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 4 May 2022 (actual)
- 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.
Chronic kidney disease (CKD) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. CKD patients exhibit a functional vitamin K deficiency. Calcification can be prevented by vitamin K intake. The aim of this study is to investigate the cause for the vitamin K deficiency beyond a diminished dietary vitamin K uptake.
Detailed description
This study is a monocentric, 1-armed interventional trial. Participants will be recruited at the University Hospital of the RWTH Aachen.
We will analyse serially collected serum from 10 dialysis patients, after ingestion of a single vitamin K supplement, compared to healthy controls. Lipoprotein fractions will be isolated and the corresponding vitamin K contents will be measured by chromatography.
The vitamin K supplement contains 3 subforms of vitamin K: vitamin K1 (1000µg), menaquinone-4 (1000µg) and menaquinone-7 (200µg).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin K supplement | Experimental | Drug: Vitamin K supplementAdministration of a single dose vitamin K |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Controls: adequate kidney function (GFR > 60 ml/min/1,73m2)
- Patients: chronic haemodialysis
- Written consent to take part in the study
Key exclusion criteria (5 listed)
- Intake of vitamin K antagonists
- gastro-intestinal diseases interfering with vitamin K intake
- profound anemia with an Hb < 10 g/dl
- judicial or official commitment to an institution
- pregnancy and 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 K supplementAlso: High dose vitamin K1 and K2 supplementSingle dose of vitamin K supplement | Drug | Vitamin K supplement |
Primary outcome
Vitamin K content in lipoproteins
Time frame: 1 year
Assessment of vitamin K incorporation into lipoproteins
1 secondary outcome
PIVKA-II levels
Time frame: 1 year
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 4 May 2022.
- Individual participant dataSharing planned: No
Related trials for Vitamin K Deficiency
Active, not recruitingObservational study
Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk
Not yet recruiting
The OK Daily Study
Infant Vitamin K Status, Vitamin K Deficiency Bleeding
Recruiting
Vitamin K2 Supplementation in Adult Episodic Migraine
Migraine Headache, Arterial Stiffness
Recruiting
Evaluating Response to Vitamin D3 and K2 Supplementation in Healthcare Personnel
Hypovitaminosis D, Hypovitaminosis
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.
Jürgen Floege, MD principal investigator
RWTH Aachen 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 Vitamin K supplement in people with Vitamin K Deficiency, run by RWTH Aachen University at 1 site 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 4 inclusion and 5 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 4 May 2022. 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 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.
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?
Vitamin K content in lipoproteins (time frame: 1 year). 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 4 May 2022.