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Effect of Restriction of Foods Containing Phosphorus Additives

2015年3月9日 更新者:Margareth Lage Leite de Fornasari、Faculdade de Ciências Médicas da Santa Casa de São Paulo

Effect of Restriction of Foods Containing Phosphorus Additives on the Phosphatemia of Patients With End-stage Renal Disease.

Hyperphosphatemia is related to the increase in morbidity and mortality. There is greater risk for cardiovascular disease, atherosclerotic disease, secondary hyperparathyroidism, and bone disease .

The serum phosphorus level can be controlled by a combination of factors, such as: reduction of ingestion, reduction of intestinal absorption with chelating agents and increase in elimination by dialysis.

The purpose of this study is to evaluate the effect of dietary intervention consisting of the restriction of industrialized foods with phosphorus additives in chronic kidney disease patients treated with hemodialysis.

研究概览

详细说明

The consumption of foods which contain phosphorus by patients on hemodialysis should be monitored in order to reflect the current reality, due to the increase in ingestion of industrialized foods rich in phosphorus additives. Data from studies performed in the USA shows a reduction in phosphatemia with nutritional orientation to reduce foods containing additives from restaurants in the region of the study . In another study, also conducted in the USA, the researchers evaluated the phosphorus content and presence of additives in appetizers and side orders served at fast food restaurants in Cleveland. The results showed that of the appetizers, 52% were accepted by the traditional criteria for the renal diet (low content of sodium, potassium and organic or natural phosphorus), but only 16% were also free of phosphorus additives; of the side orders, 23% were accepted by the traditional criteria and 17% were exempt of phosphorus additives. Thus, only a small proportion of appetizers and side orders served at fast food restaurants were compatible with the renal diet. Considering that alimentary phosphorus has an important role in the control of phosphatemia, there is a lack of studies which evaluates the effect of foods containing phosphorus additives on phosphatemia and which, at the same time, evaluated the alimentary ingestion and the nutritional state of the chronic kidney disease patients treated with hemodialysis.

Can the elimination of foods containing phosphorus additives and their substitution for foods without additives reduce phosphatemia without altering the nutritional state of hyperphosphatemic patients on hemodialysis?

研究类型

介入性

注册 (实际的)

140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • São Paulo、巴西、01221-020
        • Faculdade de Ciências Médicas da Santa Casa de São Paulo

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • males or female ≥ 18 years of age
  • Chronic kidney disease in stage 5, on hemodialysis for at least 6 months
  • Serum phosphorus (P) greater than 5.5 mg/dL persistent in 3 previous months
  • Preserved cognitive capacity and able to read and write
  • Signed informed written consent

Exclusion Criteria:

  • Use of enteral or parenteral therapy
  • Presence of physical or cognitive limitation
  • Malabsorption diseases.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Intervention
Restriction on food containing phosphorus additives.
The substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study.
安慰剂比较:Control
Standard care.
The control group mantained the usual renal diet oriented prior to the study with a booklet.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)
大体时间:90 days
90 days

次要结果测量

结果测量
大体时间
Protein intake at baseline and final.
大体时间:90 days
90 days
Energy intake at baseline and at the final.
大体时间:90 days
90 days
Triceps skinfold at baseline and final.
大体时间:90 days
90 days
Body mass index at baseline and final
大体时间:90 days
90 days
Arm muscle area at baseline and final
大体时间:90 days
90 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Yvoty AS Sens, PHD、Faculdade de Ciências Médicas da Santa Casa de São Paulo
  • 首席研究员:Margareth LL Fornasari, RD、Faculdade de Ciências Médicas da Santa Casa de São Paulo

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2014年6月1日

研究注册日期

首次提交

2013年10月9日

首先提交符合 QC 标准的

2013年10月15日

首次发布 (估计)

2013年10月18日

研究记录更新

最后更新发布 (估计)

2015年3月10日

上次提交的符合 QC 标准的更新

2015年3月9日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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