Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
May 25, 2010 updated by: Johann Wolfgang Goethe University Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Frankfurt am Main, Germany, 60590
- Hospital of the Goethe University Frankfurt am Main
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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:
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NO_INTERVENTION: 2
Chronic hemodialysis patients randomized to no peroral supplemental nutrition
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ACTIVE_COMPARATOR: 3
Chronic hemodialysis patients randomized to peroral supplemental nutrition.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Cross sectional area of triceps m. in mid-humerus position (MRT)
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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plasma albumin < 3.6 mg/dl
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
September 1, 2009
Study Completion (ACTUAL)
May 1, 2010
Study Registration Dates
First Submitted
May 27, 2008
First Submitted That Met QC Criteria
May 29, 2008
First Posted (ESTIMATE)
May 30, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
May 26, 2010
Last Update Submitted That Met QC Criteria
May 25, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Goethe-Uni-FFM-328-07
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