Status:
COMPLETED
Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Collaborating Sponsors:
Pfrimmer Nutricia GmbH, Erlangen , Germany
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 pilo...
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 ...
Eligibility Criteria
Inclusion
- patients on hemodialysis for more than 1 year,
- Group 1: HIV infection
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00687050
Start Date
May 1 2008
End Date
May 1 2010
Last Update
May 26 2010
Active Locations (1)
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1
Hospital of the Goethe University Frankfurt am Main
Frankfurt am Main, Germany, 60590