Effect of Restriction of Foods Containing Phosphorus Additives

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

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

Conditions
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End-stage Renal Disease, Hyperphosphatemia

Intervention / Treatment
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* Other: Restriction on food containing phosphorus additives
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Restriction on food containing phosphorus additives. | Other: Restriction on food containing phosphorus additives<br>* The substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study.<br>|
| Placebo Comparator: Control<br>Standard care. | Other: Standard care<br>* The control group mantained the usual renal diet oriented prior to the study with a booklet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL) |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein intake at baseline and final. |  | 90 days | 
| Energy intake at baseline and at the final. |  | 90 days | 
| Triceps skinfold at baseline and final. |  | 90 days | 
| Body mass index at baseline and final |  | 90 days | 
| Arm muscle area at baseline and final |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Phosphorus, Diet