How to Prevent Renal Cachexia? A Clinical Randomized Pilot Study Testing Oral Supplemental Nutrition in Hemodialysis Patients With and Without Human Immunodeficiency Virus Infection

Objective End-stage renal disease associates with catabolism and sarcopenia. Hypothetically, peroral supplemental nutrition over 6 months prevents catabolism in hemodialysis patients. Design Prospective randomized pilot study (ClinicalTrials.gov Identifier: NCT00687050). Subjects Twenty-three hemodialysis patients (15 males and 7 females) with or without human immunodeficiency virus (HIV) infection of 2 ambulatory hemodialysis centers. Intervention HIV-positive hemodialysis patients ( n  = 7, Group 1) were started on supplemental nutrition drinks (250 kcal/day), HIV-negative hemodialysis patients (n = 16, Group 2) were randomized to supplemental nutrition drinks (250 kcal/day) or received none. Main Outcome Measures Body impedance analysis, anthropometric measures, magnetic resonance imaging results for mid-iliopsoas muscle cross-sectional area and laboratory parameters including albumin, cytokines at baseline, and at 6 months follow-up. Results Seven patients in Group 1 (mean age: 50.6 ± 9.6 years) and 16 patients in Group 2 (mean age: 54.0 ± 13.3 years) were recruited. Serum creatinine (Group 1: 6.4 ± 3.0 mg/dL; Group 2: 10.7 ± 2.5 mg/dL; P P P Conclusions A new oral supplemental nutrition over 6 months had no treatment effect in surviving HIV-positive hemodialysis patients or in maintenance hemodialysis patients without HIV infection. The limitations of this study were small study size and unexpected high mortality among HIV-positive hemodialysis patients.