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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia; End-stage Renal Disease
• Intervention / Treatment: Other: Restriction on food containing phosphorus additives; Other: Standard care

Detailed 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 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?

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01221-020
    • Faculdade de Ciências Médicas da Santa Casa de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Restriction on food containing phosphorus additives.	Other: 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.
Placebo Comparator: Control; Standard care.	Other: Standard care; The control group mantained the usual renal diet oriented prior to the study with a booklet.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• 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 record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Diet; Dialysis; Phosphorus
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Phosphorus Metabolism Disorders; Kidney Diseases; Kidney Failure, Chronic; Hyperphosphatemia
• Other Study ID Numbers: Fornasari01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No