Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
Tracking Information | |
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First Received Date ICMJE | May 27, 2008 |
Last Updated Date | May 25, 2010 |
Start Date ICMJE | May 2008 |
Primary Completion Date | September 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Cross sectional area of triceps m. in mid-humerus position (MRT) [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00687050 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
plasma albumin < 3.6 mg/dl [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity |
Official Title ICMJE | MRT-based Pilot Study to Evaluate Peroral Supplemental Nutrition for Prevention of Cachexia in End-stage Renal Disease With and Without HIV Comorbidity |
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. |
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 ICMJE | Interventional |
Study Phase | |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
Condition ICMJE | End-Stage Renal Disease |
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Estimated Enrollment ICMJE | 30 |
Completion Date | May 2010 |
Primary Completion Date | September 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 75 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | Germany |
Administrative Information | |
NCT Number ICMJE | NCT00687050 |
Other Study ID Numbers ICMJE | Goethe-Uni-FFM-328-07 |
Has Data Monitoring Committee | No |
Responsible Party | Dr. Rainer U. Pliquett, Goethe University Frankfurt am Main |
Study Sponsor ICMJE | Johann Wolfgang Goethe University Hospitals |
Collaborators ICMJE | Pfrimmer Nutricia GmbH, Erlangen , Germany |
Investigators ICMJE | |
Information Provided By | Johann Wolfgang Goethe University Hospitals |
Verification Date | May 2010 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |