Recruitment

Recruitment Status
Completed

Inclusion Criterias

Preserved cognitive capacity and able to read and write
Signed informed written consent
Chronic kidney disease in stage 5, on hemodialysis for at least 6 months
...
Preserved cognitive capacity and able to read and write
Signed informed written consent
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
males or female ≥ 18 years of age

Exclusion Criterias

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

Summary

Conditions
  • End-stage Renal Disease
  • Hyperphosphatemia
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 w...

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?

Inclusion Criterias

Preserved cognitive capacity and able to read and write
Signed informed written consent
Chronic kidney disease in stage 5, on hemodialysis for at least 6 months
...
Preserved cognitive capacity and able to read and write
Signed informed written consent
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
males or female ≥ 18 years of age

Exclusion Criterias

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

Locations

São Paulo, 01221-020
São Paulo, 01221-020

Tracking Information

NCT #
NCT01965379
Collaborators
Not Provided
Investigators
  • Study Chair: Yvoty AS Sens, PHD Faculdade de Ciências Médicas da Santa Casa de São Paulo Principal Investigator: Margareth LL Fornasari, RD Faculdade de Ciências Médicas da Santa Casa de São Paulo
  • Study Chair: Yvoty AS Sens, PHD Faculdade de Ciências Médicas da Santa Casa de São Paulo Margareth LL Fornasari, RD Faculdade de Ciências Médicas da Santa Casa de São Paulo