Effect of Restriction of Foods Containing Phosphorus Additives
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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São Paulo、巴西、01221-020
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
-
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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.
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The substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study.
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|
安慰剂比较:Control
Standard care.
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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
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
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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