Egg White for Phosphorus Control in Haemodialysis Patients (UAUDIPE)
Primary Purpose
Renal Insufficiency, Chronic, Dialysis, Hyperphosphatemia
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Egg White replacement
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring hyperphosphatemia, hemodialysis, dietary treatment, egg white, protein energy wasting
Eligibility Criteria
Inclusion Criteria:
- thrice weekly 4 h standard bicarbonate HD treatment with an at least 6-month vintage
- stable dialysis dose and modality at least by 3 months
- hyperphosphataemia (serum phosphate ≥5.0 mg/dl) at least by 3 months
- stable dietary intake at least by 3 months
- stable body weight at least by 3 months
- stable biochemical markers at least by 3 months
Exclusion Criteria:
- diabetes
- liver disease
- malignancy
- previous parathyroidectomy
- psychiatric diseases
- non-collaborative patients
Sites / Locations
- Federico II University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
usual diet
egg white instead of meat or fish in two meals twice a week for three months
Outcomes
Primary Outcome Measures
Decrease in serum phosphate levels
This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia
Secondary Outcome Measures
Changes in body composition assessed by bioelectrical impedance analysis
Protein malnutrition causes a decrease in body cell mass. By bioelectrical impedance analysis (BIA) the changes in this parameter in the two experimental groups will be evaluated at one, two and three months from the beginning of the study.
Changes in serum albumin concentration
Protein malnutrition causes a decrease in serum albumin concentration that will be, therefore, monitored, at one, two and three months from the beginning of the study.
Changes in hemoglobin levels
Protein malnutrition causes a decrease in hemoglobin levels that will be, therefore, monitored, at one, two and three months from the beginning of the study.
Full Information
NCT ID
NCT03236701
First Posted
July 24, 2017
Last Updated
September 14, 2017
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT03236701
Brief Title
Egg White for Phosphorus Control in Haemodialysis Patients
Acronym
UAUDIPE
Official Title
The Impact of a Nutritional Intervention Based on Egg White for Phosphorus Control in Haemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 15, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish included in two meals a week with an amount of egg white containing the same quantity of proteins.
Detailed Description
Hyperphosphatemia develops in the majority of patients with end-stage renal disease (ESRD). It is responsible for severe complications such as mineral bone disease, and has a role in worsening the cardiovascular mortality of dialyzed patients. Therefore, a close control of serum phosphorus remains a cornerstone in the clinical management of dialyzed patients to improve their long term prognosis. There are multiple sources of phosphorus in the diet that could be the target of such a dietary intervention but, because of important differences in bioavailability, they are not all equally relevant in influencing phosphatemia. Among them animal proteins that have a bioavailability of about 60% represent an important target for phosphate-lowering nutritional interventions. However, lowering the protein content of the diet in hemodialysis (HD) patients may be dangerous because it may increase the the risk of malnutrition hence worsening their prognosis. In the present study we intend to explore an alternative strategy to lower the intake of phosphate with animal proteins by replacing the meat or fish included in two meals a week with egg white that is reach of proteins but has virtually no phosphate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Dialysis, Hyperphosphatemia
Keywords
hyperphosphatemia, hemodialysis, dietary treatment, egg white, protein energy wasting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
usual diet
Arm Title
Intervention
Arm Type
Experimental
Arm Description
egg white instead of meat or fish in two meals twice a week for three months
Intervention Type
Other
Intervention Name(s)
Egg White replacement
Intervention Description
Nutritional intervention: the meat or fish of two meals will be replaced twice a week with an equivalent amount (in protein content) of egg white.
Primary Outcome Measure Information:
Title
Decrease in serum phosphate levels
Description
This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia
Time Frame
Phosphate level will be measured monthly for three months from the beginning of the study
Secondary Outcome Measure Information:
Title
Changes in body composition assessed by bioelectrical impedance analysis
Description
Protein malnutrition causes a decrease in body cell mass. By bioelectrical impedance analysis (BIA) the changes in this parameter in the two experimental groups will be evaluated at one, two and three months from the beginning of the study.
Time Frame
BIA will be performed monthly for three months from the beginning of the study
Title
Changes in serum albumin concentration
Description
Protein malnutrition causes a decrease in serum albumin concentration that will be, therefore, monitored, at one, two and three months from the beginning of the study.
Time Frame
Serum albumin will be measured monthly for three months from the beginning of the study
Title
Changes in hemoglobin levels
Description
Protein malnutrition causes a decrease in hemoglobin levels that will be, therefore, monitored, at one, two and three months from the beginning of the study.
Time Frame
hemoglobin level will be measured monthly for three months from the beginning of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
thrice weekly 4 h standard bicarbonate HD treatment with an at least 6-month vintage
stable dialysis dose and modality at least by 3 months
hyperphosphataemia (serum phosphate ≥5.0 mg/dl) at least by 3 months
stable dietary intake at least by 3 months
stable body weight at least by 3 months
stable biochemical markers at least by 3 months
Exclusion Criteria:
diabetes
liver disease
malignancy
previous parathyroidectomy
psychiatric diseases
non-collaborative patients
Facility Information:
Facility Name
Federico II University Hospital
City
Napoli
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30459073
Citation
Guida B, Parolisi S, Coco M, Ruoppo T, Veccia R, di Maro M, Trio R, Memoli A, Cataldi M. The impact of a nutritional intervention based on egg white for phosphorus control in hemodialyis patients. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):45-50. doi: 10.1016/j.numecd.2018.09.010. Epub 2018 Sep 28.
Results Reference
derived
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Egg White for Phosphorus Control in Haemodialysis Patients
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