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Egg White for Phosphorus Control in Haemodialysis Patients

NCT ID: NCT03236701

Last Updated: 2017-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2017-12-15

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.

Conditions

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Renal Insufficiency, Chronic Dialysis Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

usual diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

egg white instead of meat or fish in two meals twice a week for three months

Group Type EXPERIMENTAL

Egg White replacement

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Bruna Guida

Associate Professor in Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federico II University Hospital

Napoli, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 30459073 (View on PubMed)

Other Identifiers

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76/17

Identifier Type: -

Identifier Source: org_study_id