title: Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial.
abstract: OBJECTIVE
  To determine whether children with calcium-deficiency rickets have a better response to treatment with vitamin D and calcium than with calcium alone.
  
  
  METHODS
  Randomised controlled trial.
  
  
  METHODS
  Jos University Teaching Hospital, Jos, Nigeria.
  
  
  METHODS
  Nigerian children with active rickets treated with calcium carbonate as limestone (approximately 938 mg elemental calcium twice daily) were, in addition, randomised to receive either oral vitamin D2 50,000 IU (Ca+D, n=44) or placebo (Ca, n=28) monthly for 24 weeks.
  
  
  METHODS
  Achievement of a 10-point radiographic severity score ≤1.5 and serum alkaline phosphatase ≤350 U/L.
  
  
  RESULTS
  The median (range) age of enrolled children was 46 (15-102) months, and baseline characteristics were similar in the two groups. Mean (±SD) 25-hydroxyvitamin D (25(OH)D) was 30.2±13.2 nmol/L at baseline, and 29 (43%) had values <30 nmol/L. Baseline alkaline phosphatase and radiographic scores were unrelated to vitamin D status. Of the 68 children (94% of original cohort) who completed 24 weeks of treatment, 29 (67%) in the Ca+D group and 11 (44%) in the Ca group achieved the primary outcome (p=0.06). Baseline 25(OH)D did not alter treatment group effects (p=0.99 for interaction). At the end of 24 weeks, 25(OH)D values were 55.4±17.0 nmol/L and 37.9±20.0 nmol/L in the Ca+D and Ca groups, respectively, (p<0.001). In the Ca+D and Ca groups, the final 25(OH)D concentration was greater in those who achieved the primary outcome (56.4±17.2 nmol/L) than in those who did not (37.7±18.5 nmol/L, p<0.001).
  
  
  CONCLUSIONS
  In children with calcium-deficiency rickets, there is a trend for vitamin D to improve the response to treatment with calcium carbonate as limestone, independent of baseline 25(OH)D concentrations.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00949832.
authors.affiliation: Department of Family Medicine, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Tom D
authors.initials: TD
authors.lastname: Thacher
authors.affiliation: Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Philip R
authors.initials: PR
authors.lastname: Fischer
authors.affiliation: MRC/Wits Developmental Pathways for Health Research Unit, Department of Paediatrics, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: John M
authors.initials: JM
authors.lastname: Pettifor
mesh_terms: D015502:Absorptiometry, Photon; D000469:Alkaline Phosphatase / Q000097:blood; D002118:Calcium / Q000172:deficiency*; D002648:Child; D002675:Child, Preschool; D004872:Ergocalciferols / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009549:Nigeria; D012279:Rickets / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood
chemical_list: D004872:Ergocalciferols; D014807:Vitamin D; C104450:25-hydroxyvitamin D; D000469:Alkaline Phosphatase; D002118:Calcium
references.citation: Methods Mol Biol. 2010;603:509-17
references.pmid: 20077103
references.citation: N Engl J Med. 1999 Aug 19;341(8):563-8
references.pmid: 10451461
references.citation: J Bone Miner Res. 2008 Nov;23(11):1859-63
references.pmid: 18597633
references.citation: J Trop Pediatr. 2000 Jun;46(3):132-9
references.pmid: 10893912
references.citation: J Clin Endocrinol Metab. 2009 Sep;94(9):3314-21
references.pmid: 19567516
references.citation: BMJ. 2006 Jun 24;332(7556):1506-8
references.pmid: 16793819
references.citation: JAMA. 2005 Nov 9;294(18):2336-41
references.pmid: 16278362
references.citation: J Bone Miner Res. 2010 Sep;25(9):1988-95
references.pmid: 20499377
references.citation: Bone. 2012 May;50(5):1074-80
references.pmid: 22373953
references.citation: Bone. 2013 Jul;55(1):64-8
references.pmid: 23567161
references.citation: J Pediatr. 2006 Dec;149(6):840-4
references.pmid: 17137904
references.citation: Clin Biochem. 2012 Aug;45(12):880-6
references.pmid: 22414785
references.citation: J Trop Pediatr. 2013 Apr;59(2):127-33
references.pmid: 23104564