Dialysis, Hyperphosphatemia, Renal Insufficiency, Chronic
Conditions
Keywords
hyperphosphatemia, hemodialysis, dietary treatment, egg white, protein energy wasting
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.
Interventions
OTHEREgg 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.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in serum phosphate levels | Phosphate level will be measured monthly for three months from the beginning of the study | This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body composition assessed by bioelectrical impedance analysis | BIA will be performed monthly for three months from the beginning of the study | 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. |
| Changes in serum albumin concentration | Serum albumin will be measured monthly for three months from the beginning of the study | 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. |
| Changes in hemoglobin levels | hemoglobin level will be measured monthly for three months from the beginning of the study | 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. |
Countries
Italy
Outcome results
None listed