Effect of Restriction of Foods Containing Phosphorus Additives

NCT ID: NCT01965379

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-06-30

Brief 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.

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?

Conditions

End-stage Renal Disease; Hyperphosphatemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

Restriction on food containing phosphorus additives.

Group Type: ACTIVE_COMPARATOR

Restriction on food containing phosphorus additives

Intervention Type: OTHER

The substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study.

Control

Standard care.

Group Type: PLACEBO_COMPARATOR

Standard care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Standard care

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Margareth Lage Leite de Fornasari

PHD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yvoty AS Sens, PHD

Role: STUDY_CHAIR

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Margareth LL Fornasari, RD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Locations

Faculdade de Ciências Médicas da Santa Casa de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Fornasari01

Identifier Type: -

Identifier Source: org_study_id