Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
|ClinicalTrials.gov Identifier: NCT00687050|
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : May 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|End-Stage Renal Disease||Dietary Supplement: peroral high-caloric supplemental nutrition Dietary Supplement: peroral supplemental nutrition||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||May 2010|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687050
|Hospital of the Goethe University Frankfurt am Main|
|Frankfurt am Main, Germany, 60590|