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.
調査の概要
詳細な説明
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?
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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São Paulo、ブラジル、01221-020
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change the serum levels of phosphorus to acceptable levels ( under 5.5 mg per dL)
時間枠：90 days
|
90 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Protein intake at baseline and final.
時間枠：90 days
|
90 days
|
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Energy intake at baseline and at the final.
時間枠：90 days
|
90 days
|
|
Triceps skinfold at baseline and final.
時間枠：90 days
|
90 days
|
|
Body mass index at baseline and final
時間枠：90 days
|
90 days
|
|
Arm muscle area at baseline and final
時間枠：90 days
|
90 days
|
協力者と研究者
捜査官
- スタディチェア：Yvoty AS Sens, PHD、Faculdade de Ciências Médicas da Santa Casa de São Paulo
- 主任研究者：Margareth LL Fornasari, RD、Faculdade de Ciências Médicas da Santa Casa de São Paulo
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。