End Stage Renal Disease on DialysisPhase 2/3NCT04477811
Comparative Study Evaluating the Effect of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients
A Phase 2/3 study testing Vitamin K1 and Vitamin k2 in people with End Stage Renal Disease on Dialysis, run by Ain Shams University at 1 site in Egypt.
Trial summary
To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on circulating levels of calcification regulators and to assess their safety in patients on regular dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Vitamin K1 and Vitamin k2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2020to 1 Jan 2021
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes aged between 18-75 years
- Patients on HD greater than 3 months at least.
- Stable clinical condition (no hospitalization in the previous 3 months)
Who cannot join
- Hypersensitivity to vitamin k
- Participant in an another clinical trial within the past 4 weeks.
- Judged to be unsuitable as a subject by the attending physician.
- Patients taking warfarin
- Patients with known intestinal malabsorption
- Patients with hypercoagulable state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Evaluating the Effect of the Administration of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients
To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on circulating levels of calcification regulators and to assess their safety in patients on regular dialysis patients.
Read the detailed description
Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity and mortality, especially in chronic kidney disease .
It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as overall mortality and even poor arteriovenous graft maturation .
Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor of tissue calcification, functional vitamin K deficiency may contribute to high vascular calcification (VC) burden in haemodialysis patients; this is process in which mineral is pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such as the aorta and the coronary, carotid, and peripheral arteries.
it is Prospective, Randomized,Placebo Controlled Study
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Vitamin K1, Vitamin k2, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K1Drug
Also called Phylloquinone
vitamin k1 tablets
Vitamin k2Drug
Also called menaquinone
vitamin k2 45 ug tablets twice daily
placeboOther
placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| vitamin k1 | Active comparator | vitamin k1 will be given 10 mg thrice a week for 3 months Receives: Drug: Vitamin K1 |
| vitamin k2 | Active comparator | vitamin k2 (menaquinone) will be given 90 ug per day orally Receives: Drug: Vitamin k2 |
| placebo | Placebo comparator | placebo will be given daily per oral for 3 months Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serum level of Uncarboxylated MGP
Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification
Measured: change between baseline and after 3 months
Secondary outcomes (3)
parathyroid hormone
measuring change in serum PTH
Measured: change between baseline and after 3 months
serum calcium level
measuring the change in serum calcium level
Measured: change between baseline and after 3 months
serum phosphate level
measuring the change in phosphate level
Measured: change between baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start25 Jul 2020
- Primary completion1 Nov 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Farid, Ain Shams University
- Investigators
- sarah fahmy, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477811
- Sponsor's protocol ID
- vitamin k in dialysis patients
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palit S, Kendrick J. Vascular calcification in chronic kidney disease: role of disordered mineral metabolism. Curr Pharm Des. 2014;20(37):5829-33. doi: 10.2174/1381612820666140212194926.
PubMed 24533939McCabe KM, Adams MA, Holden RM. Vitamin K status in chronic kidney disease. Nutrients. 2013 Nov 7;5(11):4390-8. doi: 10.3390/nu5114390.
PubMed 24212088
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Evaluating the Effect of the Administration of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients
- ClinicalTrials.gov ID
- NCT04477811
- Acronym / sponsor ID
- vitamin k in dialysis patients
- Conditions
- End Stage Renal Disease on Dialysis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 20 Jul 2020 (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.
To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on circulating levels of calcification regulators and to assess their safety in patients on regular dialysis patients.
Detailed description
Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity and mortality, especially in chronic kidney disease .
It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as overall mortality and even poor arteriovenous graft maturation .
Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor of tissue calcification, functional vitamin K deficiency may contribute to high vascular calcification (VC) burden in haemodialysis patients; this is process in which mineral is pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such as the aorta and the coronary, carotid, and peripheral arteries.
it is Prospective, Randomized,Placebo Controlled Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vitamin k1 | Active comparator | Drug: Vitamin K1vitamin k1 will be given 10 mg thrice a week for 3 months |
| vitamin k2 | Active comparator | Drug: Vitamin k2vitamin k2 (menaquinone) will be given 90 ug per day orally |
| placebo | Placebo comparator | Other: placeboplacebo will be given daily per oral for 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both sexes aged between 18-75 years
- Patients on HD greater than 3 months at least.
- Stable clinical condition (no hospitalization in the previous 3 months)
Key exclusion criteria (6 listed)
- Hypersensitivity to vitamin k
- Participant in an another clinical trial within the past 4 weeks.
- Judged to be unsuitable as a subject by the attending physician.
- Patients taking warfarin
- Patients with known intestinal malabsorption
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 K1Also: Phylloquinonevitamin k1 tablets | Drug | vitamin k1 |
| Vitamin k2Also: menaquinonevitamin k2 45 ug tablets twice daily | Drug | vitamin k2 |
| placeboplacebo tablets | Other | placebo |
Primary outcome
change in serum level of Uncarboxylated MGP
Time frame: change between baseline and after 3 months
Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification
3 secondary outcomes
parathyroid hormone
Time frame: change between baseline and after 3 months
serum calcium level
Time frame: change between baseline and after 3 months
serum phosphate level
Time frame: change between baseline and after 3 months
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 21 Jul 2021.
- Background: PubMed 24533939Palit S, Kendrick J. Vascular calcification in chronic kidney disease: role of disordered mineral metabolism. Curr Pharm Des. 2014;20(37):5829-33. doi: 10.2174/1381612820666140212194926.
- Background: PubMed 24212088McCabe KM, Adams MA, Holden RM. Vitamin K status in chronic kidney disease. Nutrients. 2013 Nov 7;5(11):4390-8. doi: 10.3390/nu5114390.
- Individual participant dataSharing planned: No
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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.
sarah fahmy principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin K1 and Vitamin k2 in people with End Stage Renal Disease on Dialysis, run by Ain Shams University at 1 site in Egypt.
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 6 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 21 Jul 2021. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
change in serum level of Uncarboxylated MGP (time frame: change between baseline and after 3 months). 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 NCT04477811, which also lists 2 linked publications.
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 21 Jul 2021.