Clinical trial NCT03236701: Egg White for Phosphorus Control in Haemodialysis Patients
Official title: The Impact of a Nutritional Intervention Based on Egg White for Phosphorus Control in Haemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency, Chronic
Dialysis
Hyperphosphatemia
Keywords: hyperphosphatemia
hemodialysis
dietary treatment
egg white
protein energy wasting
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Decrease in serum phosphate levels
timeFrame: Phosphate level will be measured monthly for three months from the beginning of the study
Secondary outcomes:
measure: Changes in body composition assessed by bioelectrical impedance analysis
timeFrame: BIA will be performed monthly for three months from the beginning of the study
measure: Changes in serum albumin concentration
timeFrame: Serum albumin will be measured monthly for three months from the beginning of the study
measure: Changes in hemoglobin levels
timeFrame: hemoglobin level will be measured monthly for three months from the beginning of the study
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Federico II University Hospital
Study officials:
References:
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.