Ignite Creation Date:
2025-12-18 @ 8:21 AM
Ignite Modification Date:
2025-12-23 @ 9:58 PM
Study NCT ID:
NCT03146923
Status:
None
Last Update Posted:
2020-01-18 00:00:00
First Post:
2017-04-04 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
Sponsor:
None
Organization:
Study Overview
Official Title:
Decreasing Intakes & Absorption of Phosphorus in Haemodialysis Patients Through Food Choices
Status:
None
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIP HD
Brief 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.
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: