Renal DialysisDIP HDNCT03146923
Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
A study testing Current Low Phosphorus Diet Prescription and Modified Low Phosphorus Diet Prescription in people with Renal Dialysis and Hyperphosphatemia, run by University College Cork at 10 sites in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis, Hyperphosphatemia, Dietary Modification
- What is being tested?
- Current Low Phosphorus Diet Prescription and Modified Low Phosphorus Diet Prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 10 sitesIreland
- Study dates
- 6 Mar 2017to 16 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Ireland10 sites
Cavan General Hospital
Cavan, H12 K845
Fiona Byrne
Cork, T12DC4A
St. Vincents University Hospital
Dublin, D04 T6F4
Mater Misericordia University Hospital
Dublin, D07 R2WY
Beaumont Hospital
Dublin, D09 C562
Tallaght Hospital
Dublin, D24 NR0A
Galway University Hospitals
Galway
University Hospital Limerick
Limerick, V94 F858
Mayo University Hospital
Mayo, F23 H529
Midland Regional Hospital Tullamore
Tullamore, Offaly, R35 NY51
About this study
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.
Read the 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.
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
- Renal Dialysis, Hyperphosphatemia, Dietary Modification
- Being tested
- Current Low Phosphorus Diet Prescription, Modified Low Phosphorus Diet Prescription
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current Low Phosphorus Diet PrescriptionOther
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 Low Phosphorus Diet PrescriptionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Arm | Active comparator | Patients randomised to the standard care arm will be re educated using the current low phosphorus diet prescription. Receives: 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. Receives: Other: Modified Low Phosphorus Diet Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (5)
Dietary Intake
Between arm difference in dietary phosphate intake (separating phosphate into high \& low bioavailability).
Between arm difference in dietary fibre intake.
Measured: 1 month
Serum iPTH
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.
Measured: 1 month
Palatability and Subject Acceptance (Tolerability)
Palatability and subject acceptance of modified diet as assessed by 5 point Likert Scale
Measured: 1 month
FGF23 (Exploratory Endpoint)
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).
Measured: 1 month
Serum Potassium (Safety Endpoints):
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start6 Mar 2017
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre Parallel Arm Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Cork University Hospital, Irish Nutrition & Dietetic Institute
- Responsible party
- Principal investigator, Joseph Eustace, University College Cork
- Investigators
- Joseph Eustace, MB, Principal investigator, HRB Clinical Research Facility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146923
- Sponsor's protocol ID
- 17-CRFC-01
- Acronym
- DIP HD
- Status last verified
- Jan 2020
- First submitted
- 4 Apr 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
- ClinicalTrials.gov ID
- NCT03146923
- Acronym / sponsor ID
- DIP HD / 17-CRFC-01
- Conditions
- Renal Dialysis, Hyperphosphatemia, Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Cork University Hospital, Irish Nutrition & Dietetic Institute
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicentre Parallel Arm Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Care Arm | Active comparator | Other: Current Low Phosphorus Diet PrescriptionPatients randomised to the standard care arm will be re educated using the current low phosphorus diet prescription. |
| Modified Intervention Arm | Experimental | Other: Modified Low Phosphorus Diet PrescriptionPatients randomised to the intervention arm will be educated using a modified low phosphorus diet prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current Low Phosphorus Diet PrescriptionRoutine / 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 | Other | Standard Care Arm |
| Modified Low Phosphorus Diet PrescriptionModified 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 | Other | Modified Intervention Arm |
Primary outcome
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.
5 secondary outcomes
Dietary Intake
Time frame: 1 month
Serum iPTH
Time frame: 1 month
Palatability and Subject Acceptance (Tolerability)
Time frame: 1 month
FGF23 (Exploratory Endpoint)
Time frame: 1 month
Serum Potassium (Safety Endpoints):
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- BackgroundByrne 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.
- Link to abstract of oral presentation at the American Society of Nephrology's 2018 Kidney WeekLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Eustace, MB principal investigator
HRB Clinical Research Facility
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current Low Phosphorus Diet Prescription and Modified Low Phosphorus Diet Prescription in people with Renal Dialysis and Hyperphosphatemia, run by University College Cork at 10 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Phosphate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03146923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.