Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
|End-Stage Renal Disease||Dietary Supplement: peroral high-caloric supplemental nutrition Dietary Supplement: peroral supplemental nutrition|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||MRT-based Pilot Study to Evaluate Peroral Supplemental Nutrition for Prevention of Cachexia in End-stage Renal Disease With and Without HIV Comorbidity|
- Cross sectional area of triceps m. in mid-humerus position (MRT) [ Time Frame: 6 months ]
- plasma albumin < 3.6 mg/dl [ Time Frame: 6 months ]
|Study Start Date:||May 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
HIV-positive hemodialysis patients (as a high risk group for cachexia) will be given daily drinks of Renilon 7.5 (125 ml, 2 kcal/ml) as peroral supplemental nutrition on top to their recommended high-protein, high-caloric diet.
Dietary Supplement: peroral high-caloric supplemental nutrition
HIV-positive hemodialysis patients will be given daily supplemental nutrition (125 ml, 2 kcal/ml) on top of recommended high-protein, high-caloric regular diet
Other Name: Renilon 7.5 by Pfrimmer Nutricia
No Intervention: 2
Chronic hemodialysis patients randomized to no peroral supplemental nutrition
Active Comparator: 3
Chronic hemodialysis patients randomized to peroral supplemental nutrition.
Dietary Supplement: peroral supplemental nutrition
Chronic hemodialysis patients will be given daily peroral supplemental nutrition (125 ml/d, 2 kcal/ml) on top of their recommended high-protein, high caloric diet
Other Name: Renilon 7.5 by Pfrimmer-Nutricia
In end-stage renal disease (ESRD), cachexia is a common finding. Metabolic changes, malnutrition, or both appear to be the underlying problems. In fact, lean body mass per body weight better predicts prognosis than creatinin based models (NDT, 2004.19:1182). In addition, comorbidity such as HIV infection may exacerbate cachexia found in ESRD. Whether or not daily supplemental, high-caloric nutrition in ESRD corrects a catabolic state in ESRD is unclear.
Hypothesis to be tested:
Daily supplemental high-caloric nutrition beneficially affects cytokine stimulation (TNF alpha, IL 1beta, IL 6, CrP) and nutritional state (cross sectional area of triceps m. in mid-humerus position (MRT), plasma albumin) in in HIV-positive hemodialysis patients and in chronic hemodialysis patients compared to chronic hemodialysis patients without supplemental nutrition.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687050
|Hospital of the Goethe University Frankfurt am Main|
|Frankfurt am Main, Germany, 60590|