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

NCT ID: NCT00687050

Last Updated: 2010-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-05-31

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.

Conditions

End-Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

peroral high-caloric supplemental nutrition

Intervention Type: DIETARY_SUPPLEMENT

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

2

Chronic hemodialysis patients randomized to no peroral supplemental nutrition

Group Type: NO_INTERVENTION

No interventions assigned to this group

3

Chronic hemodialysis patients randomized to peroral supplemental nutrition.

Group Type: ACTIVE_COMPARATOR

peroral supplemental nutrition

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Renilon 7.5 by Pfrimmer Nutricia; Renilon 7.5 by Pfrimmer-Nutricia

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfrimmer Nutricia GmbH, Erlangen , Germany

INDUSTRY

Sponsor Role: collaborator

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Goethe University Frankfurt am Main

Locations

Hospital of the Goethe University Frankfurt am Main

Frankfurt am Main, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 29146139 (View on PubMed)

Other Identifiers

Goethe-Uni-FFM-328-07

Identifier Type: -

Identifier Source: org_study_id