Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity

This study has been completed.
Sponsor:
Collaborator:
Pfrimmer Nutricia GmbH, Erlangen , Germany
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00687050
First received: May 27, 2008
Last updated: May 25, 2010
Last verified: May 2010

May 27, 2008
May 25, 2010
May 2008
September 2009   (final data collection date for primary outcome measure)
Cross sectional area of triceps m. in mid-humerus position (MRT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00687050 on ClinicalTrials.gov Archive Site
plasma albumin < 3.6 mg/dl [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
MRT-based Pilot Study to Evaluate Peroral Supplemental Nutrition for Prevention of Cachexia in End-stage Renal Disease With and Without HIV Comorbidity

End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic changes or both. Human immunodeficiency virus-infection may exacerbate the state of malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on hemodialysis. Non-HIV patients will be randomized to peroral supplemental nutrition or no peroral supplemental nutrition. All HIV patients will receive peroral supplemental nutrition. The nutritional state will be determined in magnet resonance tomography at the start and at the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma albumin and others). The hypothesis is that supplemental peroral nutrition (a total 250 kcal per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their counterparts without supplemental peroral nutrition) as well as in the high risk group of HIV patients. This pilot study may lead to larger randomized clinical trials and, may affect dietary recommendations.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
End-Stage Renal Disease
  • 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
  • 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
  • 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.
    Intervention: Dietary Supplement: peroral high-caloric supplemental nutrition
  • No Intervention: 2
    Chronic hemodialysis patients randomized to no peroral supplemental nutrition
  • Active Comparator: 3
    Chronic hemodialysis patients randomized to peroral supplemental nutrition.
    Intervention: Dietary Supplement: peroral supplemental nutrition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2010
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients on hemodialysis for more than 1 year,
  • Group 1: HIV infection

Exclusion Criteria:

  • patients on hemodialysis for less than 1 year,
  • Group 2 and 3: HIV infection
  • no pre-/post dialysis weight differences of > 3 kg after long HD free interval over last 10 HD sessions.
  • no current high-caloric nutrition supplements or planned high-caloric supplements for clinical reasons.
  • pregnancy
  • for women: no use of oral contraceptives or other at least equally effective contraception in women with childbearing potential
  • known neoplastic disease other than skin tumors (except melanoma)
  • mental disease or retardation with impaired judgement power
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00687050
Goethe-Uni-FFM-328-07
No
Dr. Rainer U. Pliquett, Goethe University Frankfurt am Main
Johann Wolfgang Goethe University Hospitals
Pfrimmer Nutricia GmbH, Erlangen , Germany
Not Provided
Johann Wolfgang Goethe University Hospitals
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP