Effect of Restriction of Foods Containing Phosphorus Additives

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965379
• Other study ID #: Fornasari01
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: March 9, 2015
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End-stage Renal Disease
• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.
• Standard care
The control group mantained the usual renal diet oriented prior to the study with a booklet.

Locations

Country	Name	City	State
Brazil	Faculdade de Ciências Médicas da Santa Casa de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)		90 days	No
Secondary	Protein intake at baseline and final.		90 days	No
Secondary	Energy intake at baseline and at the final.		90 days	No
Secondary	Triceps skinfold at baseline and final.		90 days	No
Secondary	Body mass index at baseline and final		90 days	No
Secondary	Arm muscle area at baseline and final		90 days	No