End Stage Renal DiseasePhase 2/3NCT04145492
Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients
A Phase 2/3 study testing Vitamin K2, Cholecalciferol (inactive vitamin D) and Vitamin K2 and Cholecalciferol in people with End Stage Renal Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Vitamin K2, Cholecalciferol (inactive vitamin D) and Vitamin K2 and Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 Feb 2020
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 6-18 years
- Patients on hemodialysis since 3 months or longer
- Hemodialysis frequency 3 times or more weekly
Who cannot join
- Patients with life expectancy < 3 months
- Patients taking warfarin
- Patients with known intestinal malabsorption
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Radwa Maher El Borolossy
Cairo, 0000
Radwa Maher El Borolossy, PhD, 01227052880, radwa.maher14@yahoo.com
About this study
Official title: The Impact of Vitamin K2 and Inactive Vitamin D Supplementation on Vascular Calcification in Pediatric Patients on Regular Hemodialysis
The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.
Read the detailed description
Vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries [3, 4]. It seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus. However, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics.
The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.
- Conditions
- End Stage Renal Disease
- Being tested
- Vitamin K2, Cholecalciferol (inactive vitamin D), Vitamin K2 and Cholecalciferol
- Keywords
- Hemodialysis and Vitamin K2
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2Drug
Also called Group 1
Patients will take 90 ug of vitamin K2
Cholecalciferol (inactive vitamin D)Drug
Also called Group 2
Patients will take 10 ug of vitamin inactive vitamin D
Vitamin K2 and CholecalciferolDrug
Also called Group 3
Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K2 group | Active comparator | 15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months. Receives: Drug: Vitamin K2 |
| Cholecalciferol group | Active comparator | 15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months. Receives: Drug: Cholecalciferol (inactive vitamin D) |
| Vitamin K2 and Cholecalciferol group | Active comparator | 15 patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D to daily in addition to the standard therapy for 4 months. Receives: Drug: Cholecalciferol (inactive vitamin D); Drug: Vitamin K2 and Cholecalciferol |
| Control group | No intervention | 15 patients will take the standard therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncarboxylated MGP
Measuring serum level of Uncarboxylated MGP as a marker for calcification
Measured: 4 months
Uncarboxylated osteocalcin
Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Sep 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Maher Abd El Kader El Borolossy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145492
- Sponsor's protocol ID
- 12
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Borolossy R, El-Farsy MS. The impact of vitamin K2 and native vitamin D supplementation on vascular calcification in pediatric patients on regular hemodialysis. A randomized controlled trial. Eur J Clin Nutr. 2022 Jun;76(6):848-854. doi: 10.1038/s41430-021-01050-w. Epub 2021 Nov 29.
PubMed 34845313
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin K2 and Inactive Vitamin D Supplementation on Vascular Calcification in Pediatric Patients on Regular Hemodialysis
- ClinicalTrials.gov ID
- NCT04145492
- Acronym / sponsor ID
- 12
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis and Vitamin K2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 30 Oct 2019 (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.
The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.
Detailed description
Vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries [3, 4]. It seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus. However, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics.
The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin K2 group | Active comparator | Drug: Vitamin K215 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months. |
| Cholecalciferol group | Active comparator | Drug: Cholecalciferol (inactive vitamin D)15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months. |
| Vitamin K2 and Cholecalciferol group | Active comparator | Drug: Cholecalciferol (inactive vitamin D), Drug: Vitamin K2 and Cholecalciferol15 patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D to daily in addition to the standard therapy for 4 months. |
| Control group | No intervention | –15 patients will take the standard therapy. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 6-18 years
- Patients on hemodialysis since 3 months or longer
- Hemodialysis frequency 3 times or more weekly
Key exclusion criteria (3 listed)
- Patients with life expectancy < 3 months
- 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 K2Also: Group 1Patients will take 90 ug of vitamin K2 | Drug | Vitamin K2 group |
| Cholecalciferol (inactive vitamin D)Also: Group 2Patients will take 10 ug of vitamin inactive vitamin D | Drug | Cholecalciferol group, Vitamin K2 and Cholecalciferol group |
| Vitamin K2 and CholecalciferolAlso: Group 3Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D | Drug | Vitamin K2 and Cholecalciferol group |
Primary outcome
Uncarboxylated MGP
Time frame: 4 months
Measuring serum level of Uncarboxylated MGP as a marker for calcification
Uncarboxylated osteocalcin
Time frame: 4 months
Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Derived from this study: PubMed 34845313El Borolossy R, El-Farsy MS. The impact of vitamin K2 and native vitamin D supplementation on vascular calcification in pediatric patients on regular hemodialysis. A randomized controlled trial. Eur J Clin Nutr. 2022 Jun;76(6):848-854. doi: 10.1038/s41430-021-01050-w. Epub 2021 Nov 29.
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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.
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 K2, Cholecalciferol (inactive vitamin D) and Vitamin K2 and Cholecalciferol in people with End Stage Renal Disease, 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 3 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: status not confirmed, as of the sponsor's last update on 30 Oct 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncarboxylated MGP (time frame: 4 months). The study lists 2 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 NCT04145492, 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 30 Oct 2019.