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Completed

NCT Number: NCT01965379

Effect of Restriction of Foods Containing Phosphorus Additives

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphosphatemia Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Ciências Médicas da Santa Casa de São Paulo

São Paulo, 01221-020, Brazil

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Restriction on food containing phosphorus additives

Other

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

Standard care

Other

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

Primary outcomes

  1. Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)

    Time frame: 90 days

Secondary outcomes

  1. Protein intake at baseline and final.

    Time frame: 90 days

  2. Energy intake at baseline and at the final.

    Time frame: 90 days

  3. Triceps skinfold at baseline and final.

    Time frame: 90 days

  4. Body mass index at baseline and final

    Time frame: 90 days

  5. Arm muscle area at baseline and final

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 18, 2013
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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