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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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São Paulo, Brasil, 01221-020
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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 komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)
Tidsramme: 90 days
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90 days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Protein intake at baseline and final.
Tidsramme: 90 days
|
90 days
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Energy intake at baseline and at the final.
Tidsramme: 90 days
|
90 days
|
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Triceps skinfold at baseline and final.
Tidsramme: 90 days
|
90 days
|
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Body mass index at baseline and final
Tidsramme: 90 days
|
90 days
|
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Arm muscle area at baseline and final
Tidsramme: 90 days
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90 days
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Yvoty AS Sens, PHD, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Hovedetterforsker: Margareth LL Fornasari, RD, Faculdade de Ciências Médicas da Santa Casa de São Paulo
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Fornasari01
Legemiddel- og utstyrsinformasjon, studiedokumenter
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