title: Effect of high-protein meals during hemodialysis combined with lanthanum carbonate in hypoalbuminemic dialysis patients: findings from the FrEDI randomized controlled trial.
abstract: BACKGROUND
  Inadequate protein intake and hypoalbuminemia, indicators of protein-energy wasting, are among the strongest mortality predictors in hemodialysis patients. Hemodialysis patients are frequently counseled on dietary phosphorus restriction, which may inadvertently lead to decreased protein intake. We hypothesized that, in hypoalbuminemic hemodialysis patients, provision of high-protein meals during hemodialysis combined with a potent phosphorus binder increases serum albumin without raising phosphorus levels.
  
  
  METHODS
  We conducted a randomized controlled trial in 110 adults undergoing thrice-weekly hemodialysis with serum albumin <4.0 g/dL recruited between July 2010 and October 2011 from eight Southern California dialysis units. Patients were randomly assigned to receive high-protein (50-55 g) meals during dialysis, providing 400-500 mg phosphorus, combined with lanthanum carbonate versus low-protein (<1 g) meals during dialysis, providing <20 mg phosphorus. Prescribed nonlanthanum phosphorus binders were continued over an 8-week period. The primary composite outcome was a rise in serum albumin of ≥0.2 g/dL while maintaining phosphorus between 3.5-<5.5 mg/dL. Secondary outcomes included achievement of the primary outcome's individual endpoints and changes in mineral and bone disease and inflammatory markers.
  
  
  RESULTS
  Among 106 participants who satisfied the trial entrance criteria, 27% ( n = 15) and 12% ( n = 6) of patients in the high-protein versus low-protein hemodialysis meal groups, respectively, achieved the primary outcome (intention-to-treat P-value = 0.045). A lower proportion of patients in the high-protein versus low-protein intake groups experienced a meaningful rise in interleukin-6 levels: 9% versus 31%, respectively (P = 0.009). No serious adverse events were observed.
  
  
  CONCLUSIONS
  In hypoalbuminemic hemodialysis patients, high-protein meals during dialysis combined with lanthanum carbonate are safe and increase serum albumin while controlling phosphorus.
authors.affiliation: Harold Simmons Center for Chronic Disease Research and Epidemiology, University of California Irvine School of Medicine, Orange, CA, USA.
authors.forename: Connie M
authors.initials: CM
authors.lastname: Rhee
authors.affiliation: Harold Simmons Center for Chronic Disease Research and Epidemiology, University of California Irvine School of Medicine, Orange, CA, USA.
authors.forename: Amy S
authors.initials: AS
authors.lastname: You
authors.affiliation: Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, CA, USA.
authors.forename: Tara
authors.initials: T
authors.lastname: Koontz Parsons
authors.affiliation: Harold Simmons Center for Chronic Disease Research and Epidemiology, University of California Irvine School of Medicine, Orange, CA, USA.
authors.forename: Amanda R
authors.initials: AR
authors.lastname: Tortorici
authors.affiliation: Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, CA, USA.
authors.forename: Rachelle
authors.initials: R
authors.lastname: Bross
authors.affiliation: Center for Healthful Behavior Change, New York University School of Medicine, New York, NY, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: St-Jules
authors.affiliation: Harold Simmons Center for Chronic Disease Research and Epidemiology, University of California Irvine School of Medicine, Orange, CA, USA.
authors.forename: Jennie
authors.initials: J
authors.lastname: Jing
authors.affiliation: UCLA Fielding School of Public Health, Los Angeles, CA, USA.
authors.forename: Martin L
authors.initials: ML
authors.lastname: Lee
authors.affiliation: DaVita Inc., El Segundo, CA, USA.
authors.forename: Debbie
authors.initials: D
authors.lastname: Benner
authors.affiliation: Division of Nephrology, University of Tennessee Health Science Center, Memphis, TN, USA.|Nephrology Section, Memphis Veterans Affairs Medical Center, Memphis, TN, USA.
authors.forename: Csaba P
authors.initials: CP
authors.lastname: Kovesdy
authors.affiliation: Kidney Research Institute and Harborview Medical Center, Division of Nephrology, University of Washington, Seattle, WA, USA.
authors.forename: Rajnish
authors.initials: R
authors.lastname: Mehrotra
authors.affiliation: UCLA Fielding School of Public Health, Los Angeles, CA, USA.|Division of Nephrology and Hypertension, Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, CA, USA.|David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
authors.forename: Joel D
authors.initials: JD
authors.lastname: Kopple
authors.affiliation: Harold Simmons Center for Chronic Disease Research and Epidemiology, University of California Irvine School of Medicine, Orange, CA, USA.|Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, CA, USA.|UCLA Fielding School of Public Health, Los Angeles, CA, USA.
authors.forename: Kamyar
authors.initials: K
authors.lastname: Kalantar-Zadeh
mesh_terms: D001847:Bone Diseases / Q000188:drug therapy* / Q000209:etiology; D004044:Dietary Proteins / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D034141:Hypoalbuminemia / Q000150:complications / Q000628:therapy*; D007811:Lanthanum / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000097:blood; D006435:Renal Dialysis
chemical_list: D004044:Dietary Proteins; D010758:Phosphorus; C119467:lanthanum carbonate; D007811:Lanthanum
keywords: hemodialysis; high-protein; hyperphosphatemia; hypoalbuminemia; protein-energy wasting