title: Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized controlled trial.
abstract: BACKGROUND
  Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking.
  
  
  OBJECTIVE
  To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m(2).
  
  
  METHODS
  Multinational, double-blind, randomized placebo-controlled trial among 227 patients with chronic kidney disease, mild to moderate left ventricular hypertrophy, and preserved left ventricular ejection fraction, conducted in 11 countries from July 2008 through September 2010.
  
  
  METHODS
  Participants were randomly assigned to receive oral paricalcitol, 2 μg/d (n =115), or matching placebo (n = 112).
  
  
  METHODS
  Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging. Secondary end points included echocardiographic changes in left ventricular diastolic function.
  
  
  RESULTS
  Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration. At 48 weeks, the change in left ventricular mass index did not differ between treatment groups (paricalcitol group, 0.34 g/m(2.7) [95% CI, -0.14 to 0.83 g/m(2.7)] vs placebo group, -0.07 g/m(2.7) [95% CI, -0.55 to 0.42 g/m(2.7)]). Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity (paricalcitol group, -0.01 cm/s [95% CI, -0.63 to 0.60 cm/s] vs placebo group, -0.30 cm/s [95% CI, -0.93 to 0.34 cm/s]) also did not differ. Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group.
  
  
  CONCLUSIONS
  Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00497146.
authors.affiliation: Division of Nephrology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114, USA. thadhani.r@mgh.harvard.edu
authors.forename: Ravi
authors.initials: R
authors.lastname: Thadhani
authors.forename: Evan
authors.initials: E
authors.lastname: Appelbaum
authors.forename: Yili
authors.initials: Y
authors.lastname: Pritchett
authors.forename: Yuchiao
authors.initials: Y
authors.lastname: Chang
authors.forename: Julia
authors.initials: J
authors.lastname: Wenger
authors.forename: Hector
authors.initials: H
authors.lastname: Tamez
authors.forename: Ishir
authors.initials: I
authors.lastname: Bhan
authors.forename: Rajiv
authors.initials: R
authors.lastname: Agarwal
authors.forename: Carmine
authors.initials: C
authors.lastname: Zoccali
authors.forename: Christoph
authors.initials: C
authors.lastname: Wanner
authors.forename: Donald
authors.initials: D
authors.lastname: Lloyd-Jones
authors.forename: Jorge
authors.initials: J
authors.lastname: Cannata
authors.forename: B Taylor
authors.initials: BT
authors.lastname: Thompson
authors.forename: Dennis
authors.initials: D
authors.lastname: Andress
authors.forename: Wuyan
authors.initials: W
authors.lastname: Zhang
authors.forename: David
authors.initials: D
authors.lastname: Packham
authors.forename: Bhupinder
authors.initials: B
authors.lastname: Singh
authors.forename: Daniel
authors.initials: D
authors.lastname: Zehnder
authors.forename: Amil
authors.initials: A
authors.lastname: Shah
authors.forename: Ajay
authors.initials: A
authors.lastname: Pachika
authors.forename: Warren J
authors.initials: WJ
authors.lastname: Manning
authors.forename: Scott D
authors.initials: SD
authors.lastname: Solomon
mesh_terms: D000368:Aged; D002908:Chronic Disease; D004311:Double-Blind Method; D004872:Ergocalciferols / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D006934:Hypercalcemia / Q000139:chemically induced; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy; D017379:Hypertrophy, Left Ventricular / Q000188:drug therapy* / Q000209:etiology; D007674:Kidney Diseases / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects*; D014808:Vitamin D Deficiency / Q000150:complications / Q000188:drug therapy* / Q000209:etiology; D014815:Vitamins / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D004872:Ergocalciferols; D010281:Parathyroid Hormone; D014815:Vitamins; C084656:paricalcitol