Dietary Modification Clinical Trial
Official title:
Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
Based on new evidence renal dietitians in Ireland are revising the diet sheet that is used to
teach patients about reducing blood phosphate. Changes that renal dietitians plan to make to
the dietary phosphorus prescription
- Inclusion of some nuts and pulses
- More detailed education re phosphate additives
- More accurate protein prescription
- Inclusion of more whole grains
- Encouraging the use of foods with a low phosphorus to protein ratio
The investigators want to test the two diet prescription to find out, which one is better at
reducing blood phosphate and which one is more acceptable to patients. The investigators also
want to make sure it is safe.
Background:
Chronic Kidney Disease (CKD) afflicts one in twenty Irish citizens who are over age 45 and is
a significant risk factor for cardiovascular disease, premature death and significantly
impacts healthcare utilisation. As kidney function deteriorates, phosphorus, upregulates
counter regulatory hormones (immunoreactive Parathyroid Hormone (iPTH) and Fibroblast Growth
Factor 23 (FGF23), the elevated levels of which are maladaptive. Collectively these
abnormalities and their complications are referred to as Chronic Kidney Disease, Mineral &
Bone Disorder (CKD MBD). Hyperphosphataemia or high blood phosphate levels is associated with
increased mortality, in dialysis patients, in the earlier stages of CKD and even in patients
with normal renal function. The use of phosphorus restricted diets in combination with oral
phosphate binders has become well established in the management of patients with CKD stages
3-5 (including CKD stage 5D).
Experts have called for research into the dietary management of phosphate in the CKD
population. The current evidence base is weak and in a recent Cochrane systematic review the
authors concluded that there was limited low quality evidence to indicate that dietary
interventions may positively affect CKD-MBD.
In recent years there has been increased focus on dietary phosphorus restriction in the
management of CKD-MBD and a number of experts have suggested changes in how we manage dietary
phosphorus. Several potential strategies have been suggested and in response the Renal
Interest Group (RIG) of the Irish Nutrition & Dietetic Institute (INDI) held a 1 day meeting
in Dublin in January 2015 which brought together numerous experts in the field to summarise
our current understanding and the recent advances in the field.
Following on from this, RIG set up a working group to translate the new knowledge from the
advanced study day and from further literature reviews into a modified low phosphate diet
sheet.
Almost all people who have end stage kidney disease (ESKD) and require dialysis to survive,
follow a dietary phosphorus restriction, to control high blood phosphate, with the aim of
reducing the risk of cardiovascular disease, fractures and death.
Research Hypothesis: The modified low phosphate diet sheet is superior to current treatment
in haemodialysis patients
Study Objectives
Primary Objective: To determine if the modified low phosphorus dietary prescription is
superior to current management in reducing serum phosphate levels in HD patients
Secondary Objectives To determine if the modified low phosphorus diet is tolerable To
determine if the modified low phosphorus diet is safe To determine if the modified low
phosphorus diet brings the renal diet closer to healthy eating advice e.g. increased fibre
intake.
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