title: Ergocalciferol supplementation in children with CKD delays the onset of secondary hyperparathyroidism: a randomized trial.
abstract: OBJECTIVE
  Vitamin D deficiency is an important contributor to the development of hyperparathyroidism and is independently associated with cardiovascular and bone disease. The hypothesis was that nutritional vitamin D (ergocalciferol) supplementation in children with CKD stages 2-4 delays the onset of secondary hyperparathyroidism.
  
  
  METHODS
  A randomized, double-blinded, placebo-controlled study in children with CKD2-4 who had 25-hydroxyvitamin D [25(OH)D] deficiency was conducted. Ergocalciferol (or a matched placebo) was given daily as per Kidney Disease Outcomes Quality Initiative guidelines. The primary endpoint was the time to development of hyperparathyroidism.
  
  
  RESULTS
  Seventy-two children were screened. Forty-seven children were 25(OH)D-deficient and randomly assigned to receive ergocalciferol or placebo. Twenty children in each arm completed the study; median follow-up was 12 months. Groups were well matched for age, race, estimated GFR, and season when recruited. Nine of 20 children on placebo and 3 of 20 children on ergocalciferol developed hyperparathyroidism (odds ratio, 4.64; 95% confidence interval, 1.02-21.00). The time to development of hyperparathyroidism was significantly longer with ergocalciferol treatment compared with placebo (hazard ratio, 0.30; 95% confidence interval, 0.09-0.93, P=0.05). With ergocalciferol treatment, normal 25(OH)D levels were achieved in all 8 children with CKD2, 8 of 11 children with CKD3, but not in the single patient with CKD4. There were no ergocalciferol-related adverse events. 25(OH)D levels >100 nmol/L were required to achieve normal levels of 1,25-dihydroxyvitamin D.
  
  
  CONCLUSIONS
  Ergocalciferol is an effective treatment that delays the development of secondary hyperparathyroidism in children with CKD2-3.
authors.affiliation: Renal Unit, Ormond Street Hospital for Children NHS Trust and Institute of Child Health, London WC1N 3JH, UK. Rukshana.Shroff@gosh.nhs.uk
authors.forename: Rukshana
authors.initials: R
authors.lastname: Shroff
authors.forename: Mandy
authors.initials: M
authors.lastname: Wan
authors.forename: Ambrose
authors.initials: A
authors.lastname: Gullett
authors.forename: Sarah
authors.initials: S
authors.lastname: Ledermann
authors.forename: Rachel
authors.initials: R
authors.lastname: Shute
authors.forename: Craig
authors.initials: C
authors.lastname: Knott
authors.forename: David
authors.initials: D
authors.lastname: Wells
authors.forename: Helen
authors.initials: H
authors.lastname: Aitkenhead
authors.forename: Bahee
authors.initials: B
authors.lastname: Manickavasagar
authors.forename: William
authors.initials: W
authors.lastname: van't Hoff
authors.forename: Lesley
authors.initials: L
authors.lastname: Rees
mesh_terms: D000293:Adolescent; D000704:Analysis of Variance; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D019587:Dietary Supplements; D004311:Double-Blind Method; D004872:Ergocalciferols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008131:London; D008297:Male; D016017:Odds Ratio; D010919:Placebos; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D014815:Vitamins / Q000627:therapeutic use*
chemical_list: D015415:Biomarkers; D004872:Ergocalciferols; D010919:Placebos; D014815:Vitamins; D014807:Vitamin D; C104450:25-hydroxyvitamin D