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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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?
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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São Paulo, Brazilië, 01221-020
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Intervention
Restriction on food containing phosphorus additives.
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The substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study.
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Placebo-vergelijker: Control
Standard care.
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The control group mantained the usual renal diet oriented prior to the study with a booklet.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)
Tijdsspanne: 90 days
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90 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Protein intake at baseline and final.
Tijdsspanne: 90 days
|
90 days
|
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Energy intake at baseline and at the final.
Tijdsspanne: 90 days
|
90 days
|
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Triceps skinfold at baseline and final.
Tijdsspanne: 90 days
|
90 days
|
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Body mass index at baseline and final
Tijdsspanne: 90 days
|
90 days
|
|
Arm muscle area at baseline and final
Tijdsspanne: 90 days
|
90 days
|
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Yvoty AS Sens, PHD, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Hoofdonderzoeker: Margareth LL Fornasari, RD, Faculdade de Ciências Médicas da Santa Casa de São Paulo
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Fornasari01
Informatie over medicijnen en apparaten, studiedocumenten
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