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

End-Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687050
• Other study ID #: Goethe-Uni-FFM-328-07
• Status: Completed
• Phase: N/A
• First received: May 27, 2008
• Last updated: May 25, 2010
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Hospital of the Goethe University Frankfurt am Main	Frankfurt am Main

Sponsors (2)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals	Pfrimmer Nutricia GmbH, Erlangen , Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross sectional area of triceps m. in mid-humerus position (MRT)		6 months	No
Secondary	plasma albumin < 3.6 mg/dl		6 months	No