Clinical trial NCT00687050: Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: end-stage renal disease
chronic kidney disease
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Pfrimmer Nutricia GmbH, Erlangen , Germany
First posted: 2008-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cross sectional area of triceps m. in mid-humerus position (MRT)
timeFrame: 6 months
Secondary outcomes:
measure: plasma albumin < 3.6 mg/dl
timeFrame: 6 months
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Hospital of the Goethe University Frankfurt am Main
Study officials:
References:
citation: Zilles M, Betz C, Jung O, Gauer S, Hammerstingl R, Wachtershauser A, Vogl TJ, Geiger H, Asbe-Vollkopf A, Pliquett RU. How to Prevent Renal Cachexia? A Clinical Randomized Pilot Study Testing Oral Supplemental Nutrition in Hemodialysis Patients With and Without Human Immunodeficiency Virus Infection. J Ren Nutr. 2018 Jan;28(1):37-44. doi: 10.1053/j.jrn.2017.07.003. Epub 2017 Nov 14.