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临床试验/NCT03236701
NCT03236701Unknown不适用

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

Federico II University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Decrease in serum phosphate levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •liver disease
  • •malignancy
  • •previous parathyroidectomy
  • •psychiatric diseases
  • •non-collaborative patients

研究组 & 干预措施

Control

No Intervention

usual diet

Intervention

Experimental

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

干预措施: Egg White replacement (Other)

结局指标

主要结局

Decrease in serum phosphate levels

时间窗: 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

次要结局

  • Changes in body composition assessed by bioelectrical impedance analysis(BIA will be performed monthly for 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)
  • Changes in hemoglobin levels(hemoglobin level will be measured monthly for three months from the beginning of the study)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruna Guida

Associate Professor in Physiology

Federico II University

研究点 (1)

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