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

NCT03146923 | Completed

• 1 other identifier: 17-CRFC-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 10

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.

Conditions

Renal Dialysis; Hyperphosphatemia; Dietary Modification

Outcome Measures

Primary Outcomes (1)

• Serum Phosphate

  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.

  1 month

Secondary Outcomes (5)

• Dietary Intake

  1 month

• Serum iPTH

  1 month

• Palatability and Subject Acceptance (Tolerability)

  1 month

• FGF23 (Exploratory Endpoint)

  1 month

• Serum Potassium (Safety Endpoints):

  1 month

Study Arms (2)

Standard Care Arm

ACTIVE COMPARATOR

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

Other: Current Low Phosphorus Diet Prescription

Modified Intervention Arm

EXPERIMENTAL

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

Other: Modified Low Phosphorus Diet Prescription

Interventions

Current Low Phosphorus Diet Prescription 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

Standard Care Arm

Modified Low Phosphorus Diet Prescription 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

Modified Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead
• Cork University Hospital: collaborator
• Irish Nutrition & Dietetic Institute: collaborator

Study Sites (10)

Midland Regional Hospital Tullamore

Tullamore, Offaly, R35 NY51, Ireland

Location

Cavan General Hospital

Cavan, H12 K845, Ireland

Location

Fiona Byrne

Cork, T12DC4A, Ireland

Location

St. Vincents University Hospital

Dublin, D04 T6F4, Ireland

Location

Mater Misericordia University Hospital

Dublin, D07 R2WY, Ireland

Location

Beaumont Hospital

Dublin, D09 C562, Ireland

Location

Tallaght Hospital

Dublin, D24 NR0A, Ireland

Location

Galway University Hospitals

Galway, Ireland

Location

University Hospital Limerick

Limerick, V94 F858, Ireland

Location

Mayo University Hospital

Mayo, F23 H529, Ireland

Location

Related Publications (1)

• Byrne F, Gillman B, Renal Interest Group INDI, Eustace J. Multicentre Randomized Control Trial of Phosphate Control with a Modified as Compared to Standard Renal Diet TH-OR030. J Am Soc Nephrol 2018;29:8.

  BACKGROUND

Related Links

• Link to abstract of oral presentation at the American Society of Nephrology's 2018 Kidney Week

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joseph Eustace, MB

  HRB Clinical Research Facility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of HRB Clinical Research Facility Cork

Model Details: Multicentre Parallel Arm Randomised Controlled Trial

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: May 10, 2017
• Study Start: March 6, 2017
• Primary Completion: June 16, 2017
• Study Completion: June 16, 2017
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (10)