None listed
Conditions
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.
Interventions
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.
Sponsors
Waitemata District Health Board
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed