Egg White for Phosphorus Control in Haemodialysis Patients (UAUDIPE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Insufficiency, Chronic; Hyperphosphatemia; Dialysis
• Intervention / Treatment: Other: Egg White replacement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Federico II University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 15, 2017

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: hemodialysis; hyperphosphatemia; protein energy wasting; dietary treatment; egg white
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Phosphorus Metabolism Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Hyperphosphatemia
• Other Study ID Numbers: 76/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No