Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College Cork
- Enrollment
- 74
- Locations
- 10
- Primary Endpoint
- Serum Phosphate
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard Care Arm
Patients randomised to the standard care arm will be re educated using the current low phosphorus diet prescription.
Intervention: Current Low Phosphorus Diet Prescription (Other)
Modified Intervention Arm
Patients randomised to the intervention arm will be educated using a modified low phosphorus diet prescription.
Intervention: Modified Low Phosphorus Diet Prescription (Other)
Outcomes
Primary Outcomes
Serum Phosphate
Time Frame: 1 month
Difference in serum phosphate value at 1 month v baseline, in those randomised to the modified diet compared to the difference in serum phosphate value at 1 month v baseline in those randomised to standard care.
Secondary Outcomes
- Palatability and Subject Acceptance (Tolerability)(1 month)
- Dietary Intake(1 month)
- Serum Potassium (Safety Endpoints):(1 month)
- FGF23 (Exploratory Endpoint)(1 month)
- Serum iPTH(1 month)
Investigators
Joseph Eustace
Director of HRB Clinical Research Facility Cork
University College Cork