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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Dietary Intake [ Time Frame: 1 month ]

    Between arm difference in dietary phosphate intake (separating phosphate into high & low bioavailability).

    Between arm difference in dietary fibre intake.

  • Serum iPTH [ Time Frame: 1 month ]
    Difference in serum iPTH value at 1 month v baseline, in those randomised to the modified diet compared to the difference in serum iPTH value at 1 month v baseline in those randomised to standard care.
  • Palatability and Subject Acceptance (Tolerability) [ Time Frame: 1 month ]
    Palatability and subject acceptance of modified diet as assessed by 5 point Likert Scale
  • FGF23 (Exploratory Endpoint) [ Time Frame: 1 month ]
    Within subject change in geometric mean FGF-23 measurement at baseline as compared to the end of the 1 month intervention. Because of evidence that subjects with diabetes handle phosphorus differently we will analyse result for FGF 23 separately in patients with and without diabetes (Muras et al., 2013, Yoda et al., 2012).
  • Serum Potassium (Safety Endpoints): [ Time Frame: 1 month ]
    Check serum potassium in week 2. Difference in serum potassium value at 1 month v baseline, in those randomised to the modified diet compared to the difference in serum potassium value at 1 month v baseline in those randomised to standard care.


Original Secondary Outcome: Same as current

Information By: University College Cork

Dates:
Date Received: April 4, 2017
Date Started: March 6, 2017
Date Completion: June 16, 2017
Last Updated: May 5, 2017
Last Verified: May 2017