Egg White for Phosphorus Control in Haemodialysis Patients

Renal Insufficiency, Chronic Clinical Trial

— UAUDIPE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03236701
• Other study ID #: 76/17
• Status: Active, not recruiting
• Phase: N/A
• First received: July 24, 2017
• Last updated: September 14, 2017
• Start date: June 15, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: September 2017
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 15, 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis
• Hyperphosphatemia
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Italy	Federico II University Hospital	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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