Egg White for Phosphorus Control in Haemodialysis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of a Nutritional Intervention Based on Egg White for Phosphorus Control in Haemodialysis Patients

Conditions
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Renal Insufficiency, Chronic, Dialysis, Hyperphosphatemia

Intervention / Treatment
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* Other: Egg White replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>usual diet | |
| Experimental: Intervention<br>egg white instead of meat or fish in two meals twice a week for three months | Other: Egg White replacement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in serum phosphate levels | This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia | Phosphate level will be measured monthly for three months from the beginning of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | BIA will be performed monthly for 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. | Serum albumin will be measured monthly for 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. | hemoglobin level will be measured monthly for three months from the beginning of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperphosphatemia, hemodialysis, dietary treatment, egg white, protein energy wasting