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Completed

NCT Number: NCT00687050

Peroral Supplemental Nutrition 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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the Goethe University Frankfurt am Main

Frankfurt am Main, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peroral high-caloric supplemental nutrition

Dietary Supplement

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 names: Renilon 7.5 by Pfrimmer Nutricia

peroral supplemental nutrition

Dietary Supplement

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 names: Renilon 7.5 by Pfrimmer-Nutricia

Primary outcomes

  1. Cross sectional area of triceps m. in mid-humerus position (MRT)

    Time frame: 6 months

Secondary outcomes

  1. plasma albumin < 3.6 mg/dl

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Collaborators

  • Pfrimmer Nutricia GmbH, Erlangen , Germany

Registry information

Official study title

MRT-based Pilot Study to Evaluate Peroral Supplemental Nutrition for Prevention of Cachexia in End-stage Renal Disease With and Without HIV Comorbidity

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
May 30, 2008
Registry last updated
May 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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