Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000282381p
Ethics application status
Not yet submitted
Date submitted
19/02/2017
Date registered
23/02/2017
Date last updated
5/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin K2 Supplementation in Haemodialysis
Scientific title
An open-label, feasibility study of Menaquinone-7 enriched supplement in haemodialysis patients.
Secondary ID [1] 291208 0
None
Universal Trial Number (UTN)
U1111-1193-2174
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 302122 0
Vascular calcification 302123 0
Condition category
Condition code
Renal and Urogenital 301737 301737 0 0
Kidney disease
Cardiovascular 301738 301738 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The product is milk enriched with Menaquinone-7.
The subject will be administered Menaquinone-7 1ug in 200ml. of milk..
Administered 3 times a week on dialysis for 8 weeks.
Patients will be administered the treatment while at dialysis so will be directly observed.
Intervention code [1] 297211 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301136 0
The tolerability of a novel functional health product enriched in MK-7 assessed by study dieticians. The product will either be classified as "Yes" tolerable or "No" not tolerable.
Timepoint [1] 301136 0
8 weeks
Primary outcome [2] 301137 0
Markers of Vitamin K deficiency will be assessed by obtaining blood samples at baseline, 8 weeks of treatment and 12 weeks (four weeks after halting treatment). Serum will be assessed for concentrations of::
Circulating dephosphorylated-uncarboxylated-matrix Gla protein,
Uncarboxylated osteocalcin and
Protein induced in vitamin K absence II
Timepoint [2] 301137 0
Baseline
8 weeks
12 weeks
Secondary outcome [1] 331814 0
5 point Likert scale to assess acceptability of the MK-7 enriched product
Timepoint [1] 331814 0
Weekly for 8 weeks

Eligibility
Key inclusion criteria
ESRD established for more than 6 months on centre or satellite haemodialysis,
Stable medical condition,
Over the age of 18 years
Are able to provide informed consent will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Therapy with warfarin,
Life expectancy of less than 6 month,
Planned renal transplantation within 3 months,
Intestinal malabsorption or significant gastrointestinal disease,
Inability to provide informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
nonparametric Kruskal-Wallis and Mann-Whitney test

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/09/2017
Actual
Date of last participant enrolment
Anticipated
1/12/2017
Actual
Date of last data collection
Anticipated
1/02/2018
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 8671 0
New Zealand
State/province [1] 8671 0

Funding & Sponsors
Funding source category [1] 295654 0
Self funded/Unfunded
Name [1] 295654 0
To be obtained
Country [1] 295654 0
Primary sponsor type
Government body
Name
Waitemata District Health Board
Address
Waitemata DHB,
Private Bag 93503,
Takapuna,
Auckland 0740
New Zealand
Country
New Zealand
Secondary sponsor category [1] 294500 0
None
Name [1] 294500 0
Address [1] 294500 0
Country [1] 294500 0
Other collaborator category [1] 279439 0
University
Name [1] 279439 0
University of Waikato
Address [1] 279439 0
School of Engineering
Private Bag 3105
Waikato 3240
Country [1] 279439 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296972 0
Health and Disability Ethics Committee
Ethics committee address [1] 296972 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 296972 0
New Zealand
Date submitted for ethics approval [1] 296972 0
01/06/2017
Approval date [1] 296972 0
Ethics approval number [1] 296972 0

Summary
Brief summary
Kidney disease is a major public health issue. The provision of dialysis has considerable economic impact; $150 million, 0.9% of the annual health budget is spent on treatment of End Stage Kidney Disease (ESKD) for <0.09% of the NZ population. There has been a steady growth in the number of patients with ESRD of 5-6% over the last 15 years. Cardiovascular disease is the major cause of mortality and a significant cause of morbidity in this group.

Menaquinone-7, a Vitamin K2 homologue is rare in the Western diet, has high potency, and a long half-life and may reduce cardiovascular disease.

We will trial if a novel health product enriched in Menaquinone-7, is tolerated in up to 30 patients with ESRD.

We will determine if the novel health product enriched in Menaquinone-7, will reverse markers of Vitamin K deficiency.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72586 0
Dr Janak de Zoysa
Address 72586 0
North Shore Hospital,
Private Bag 93503,
Takapuna,
Auckland 0740
New Zealand
Country 72586 0
New Zealand
Phone 72586 0
+6494868900
Fax 72586 0
Email 72586 0
[email protected]
Contact person for public queries
Name 72587 0
Aydin Berenjian
Address 72587 0
School of Engineering,
University of Waikato
Private Bag 3105
Hamilton 3240
Country 72587 0
New Zealand
Phone 72587 0
+64 7 858 5119
Fax 72587 0
Email 72587 0
[email protected]
Contact person for scientific queries
Name 72588 0
Aydin Berenjian
Address 72588 0
School of Engineering,
University of Waikato
Private Bag 3105
Hamilton 3240
Country 72588 0
New Zealand
Phone 72588 0
+64 7 858 5119
Fax 72588 0
Email 72588 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.