Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2017-06-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Dialysis Hyperphosphatemia Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentre Parallel Arm Randomised Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

As with most education based interventions compared to routine care it is difficult to reliably mask either the subjects or the investigators to the proposed intervention. We will attempt to blind patients referring only to the diets as diet A and diet B and avoiding the use of terminology such as old and new. We will reprint the dietary information for both arms so they do not resemble current illustrated formats.

Study Groups

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Standard Care Arm

Patients randomised to the standard care arm will be re educated using the current low phosphorus diet prescription.

Group Type ACTIVE_COMPARATOR

Current Low Phosphorus Diet Prescription

Intervention Type OTHER

Routine / Standard Care: Routine dietary intervention is currently provided by one-to-one counselling to the subject and his/her relevant family members or carers, by a state registered dietitian regarding a diet which provides \<15mg Phosphorus /g Protein (over the day). This is equivalent to approximately 1000mg P / day. This is based on the 'Eating Well with Kidney Disease' dietsheet produced by the Renal Interest Group (RIG) of the Irish Nutrition \& Dietetic Institute (INDI) in 2010 and includes following main components:

* Restricting protein intake to requirements (1-1.2g/kg Ideal Body Weight)
* Restricting dairy intake (1-1.5 portions per day)
* Avoiding foods high in phosphate
* Avoiding foods with phosphate additives

Modified Intervention Arm

Patients randomised to the intervention arm will be educated using a modified low phosphorus diet prescription.

Group Type EXPERIMENTAL

Modified Low Phosphorus Diet Prescription

Intervention Type OTHER

Modified Low Phosphorus Diet Prescription: The new prescription recommends five changes to current management

* Introduction of some plant protein in the form of pulses and nuts where the phosphorus is largely bound by phytate
* Increased focus on avoiding additives
* Introduction of more whole grains e.g. wholemeal sliced pan/ pasta/rice .
* Avoiding over-prescription of protein which carries an obligatory phosphorus load.
* Focus on high protein foods with a low phosphorus to protein ratio

Interventions

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Current Low Phosphorus Diet Prescription

Routine / Standard Care: Routine dietary intervention is currently provided by one-to-one counselling to the subject and his/her relevant family members or carers, by a state registered dietitian regarding a diet which provides \<15mg Phosphorus /g Protein (over the day). This is equivalent to approximately 1000mg P / day. This is based on the 'Eating Well with Kidney Disease' dietsheet produced by the Renal Interest Group (RIG) of the Irish Nutrition \& Dietetic Institute (INDI) in 2010 and includes following main components:

* Restricting protein intake to requirements (1-1.2g/kg Ideal Body Weight)
* Restricting dairy intake (1-1.5 portions per day)
* Avoiding foods high in phosphate
* Avoiding foods with phosphate additives

Intervention Type OTHER

Modified Low Phosphorus Diet Prescription

Modified Low Phosphorus Diet Prescription: The new prescription recommends five changes to current management

* Introduction of some plant protein in the form of pulses and nuts where the phosphorus is largely bound by phytate
* Increased focus on avoiding additives
* Introduction of more whole grains e.g. wholemeal sliced pan/ pasta/rice .
* Avoiding over-prescription of protein which carries an obligatory phosphorus load.
* Focus on high protein foods with a low phosphorus to protein ratio

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>18 years
* Self reported urine output less than 2 cups (400mls) / day
* On maintenance haemodialysis for \> 3 months
* Phosphate \>1.6mmole/L on average of last 3 available routine monthly blood tests

Exclusion Criteria

* Hyperkalemia, defined as a predialysis serum K on routine monthly blood test of \>6mmoles/l in the month preceding the trial.
* Parathyroidectomy
* Corrected serum calcium \<2.2 or \> 2.6mmol/L or local normal units where ranges varied significantly from 2.2-2.6mmoles/l.
* Acute concurrent illness, requiring hospitalisation in the 2 weeks prior to recruitment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No