title: The fluid study protocol: a randomized controlled study on the effects of bioimpedance analysis and vitamin D on left ventricular mass in peritoneal dialysis patients.
abstract: OBJECTIVE
  We will evaluate the effects of bioimpedance analysis-guided fluid management to reduce volume expansion, of vitamin D(3) supplementation, and of the combination of those techniques on decrease of left ventricular mass in peritoneal dialysis (PD) patients.
  
  
  METHODS
  This multicenter randomized controlled trial, with a 2 × 2 factorial design, will be conducted at PD clinics affiliated with 3 Canadian teaching hospitals. Consenting PD patients 18 years of age or older will be included. Patients will be excluded if they have contraindications to bioimpedance or magnetic resonance imaging, life or technique expectancy of less than 1 year, peritonitis within the preceding 3 months, or serum calcium above 2.55 mmol/L.
  
  
  METHODS
  The study will randomize 70 patients to bio-impedance-guided volume management or to usual care and to vitamin D(3) 50,000 U weekly for 8 doses, and then 10,000 U weekly or to matching placebo.
  
  
  METHODS
  The primary outcome will be change in left ventricular mass at 1 year as determined by cardiac magnetic resonance imaging. The secondary outcome will be a composite endpoint of death, nonfatal cardiovascular event, and transfer to hemodialysis for dialysis inadequacy or ultrafiltration failure. Other outcome measures will include blood pressure, quality of life, 6-minute walk test, inflammatory and fibrotic markers and their association with peritoneal membrane transport properties, and residual renal function. Patients will be followed for clinical outcomes for up to 3 years.
  
  
  CONCLUSIONS
  This study will assess whether bioimpedance-directed volume management and vitamin D(3) supplementation can improve left ventricular mass in PD patients.
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Winnie S
authors.initials: WS
authors.lastname: Su
authors.forename: Azim S
authors.initials: AS
authors.lastname: Gangji
authors.forename: Peter M
authors.initials: PM
authors.lastname: Margetts
authors.forename: Jackie
authors.initials: J
authors.lastname: Bosch
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Clase
authors.forename: Javier
authors.initials: J
authors.lastname: Ganame
authors.forename: Michael
authors.initials: M
authors.lastname: Noseworthy
authors.forename: Eva
authors.initials: E
authors.lastname: Lonn
authors.forename: Arsh K
authors.initials: AK
authors.lastname: Jain
authors.forename: Brendan
authors.initials: B
authors.lastname: McCormick
authors.forename: K Scott
authors.initials: KS
authors.lastname: Brimble
mesh_terms: D000465:Algorithms; D002762:Cholecalciferol / Q000008:administration & dosage*; D017097:Electric Impedance; D006801:Humans; D017379:Hypertrophy, Left Ventricular / Q000209:etiology* / Q000517:prevention & control*; D007676:Kidney Failure, Chronic / Q000628:therapy*; D015337:Multicenter Studies as Topic; D010530:Peritoneal Dialysis / Q000009:adverse effects; D012107:Research Design; D014808:Vitamin D Deficiency / Q000150:complications* / Q000517:prevention & control
chemical_list: D002762:Cholecalciferol