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

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ClinicalTrials.gov Identifier: NCT00687050
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : May 26, 2010
Sponsor:
Collaborator:
Pfrimmer Nutricia GmbH, Erlangen , Germany
Information provided by:
Johann Wolfgang Goethe University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Dietary Supplement: peroral high-caloric supplemental nutrition Dietary Supplement: peroral supplemental nutrition Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : May 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Cross sectional area of triceps m. in mid-humerus position (MRT) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. plasma albumin < 3.6 mg/dl [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


Locations
Germany
Hospital of the Goethe University Frankfurt am Main
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Pfrimmer Nutricia GmbH, Erlangen , Germany
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Rainer U. Pliquett, Goethe University Frankfurt am Main
ClinicalTrials.gov Identifier: NCT00687050     History of Changes
Other Study ID Numbers: Goethe-Uni-FFM-328-07
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: May 2010

Keywords provided by Johann Wolfgang Goethe University Hospital:
end-stage renal disease
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency