title: Pilot Study Evaluating Efficacy of 2 Regimens for Hypovitaminosis D Repletion in Pediatric Inflammatory Bowel Disease.
abstract: OBJECTIVE
  Vitamin D is critical for skeletal health; hypovitaminosis D is common in pediatric inflammatory bowel disease (IBD), yet optimal repletion therapy is not well studied. We aimed to conduct a pilot trial comparing the efficacy of 2 vitamin D regimens of weekly dosing for the repletion of hypovitaminosis D in pediatric IBD.
  
  
  METHODS
  Subjects identified from our IBD clinic with 25-hydroxyvitamin D (25[OH]D) concentrations <30 ng/mL were randomized to 10,000 (n = 18) or 5000 (n = 14) IU of oral vitamin D3/10 kg body weight per week for 6 weeks. Serum 25(OH)D, Ca, and parathyroid hormone concentrations were measured at baseline, week 8, and week 12.
  
  
  RESULTS
  In the higher dosing group, serum 25(OH)D increased from 23.7 ± 8.5 ng/mL at baseline to 49.2 ± 13.6 ng/mL at 8 weeks; P < 0.001. In the lower dosing group, serum 25(OH)D increased from 24.0 ± 7.0 ng/mL at baseline to 41.5 ± 9.6 ng/mL at 8 weeks; P < 0.001. At 12 weeks, serum 25(OH)D concentrations were 35.1 ± 8.4 and 30.8 ± 4.2 ng/mL for the higher and lower dose regimens, respectively. Mean serum Ca and parathyroid hormone concentrations did not significantly change during the study. No patient exhibited hypercalcemia, and no serious adverse events occurred.
  
  
  CONCLUSIONS
  Both treatment arms were safe and effective at normalizing vitamin D nutriture in pediatric IBD. Although significant repletion of 25(OH)D concentration was achieved in both dosing groups at 8 weeks, this effect was lost by the 12-week follow-up. Maintenance vitamin D therapy following initial repletion is likely required to maintain long-term normalized vitamin D status.
authors.affiliation: *Department of Pediatrics, Emory University School of Medicine †Department of Medicine, Emory University School of Medicine and the Atlanta VA Medical Center ‡Children's Healthcare of Atlanta, Atlanta, GA.
authors.forename: Robert Z
authors.initials: RZ
authors.lastname: Simek
authors.forename: Jarod
authors.initials: J
authors.lastname: Prince
authors.forename: Sana
authors.initials: S
authors.lastname: Syed
authors.forename: Cary G
authors.initials: CG
authors.lastname: Sauer
authors.forename: Bernadette
authors.initials: B
authors.lastname: Martineau
authors.forename: Tanya
authors.initials: T
authors.lastname: Hofmekler
authors.forename: Alvin J
authors.initials: AJ
authors.lastname: Freeman
authors.forename: Archana
authors.initials: A
authors.lastname: Kumar
authors.forename: Barbara O
authors.initials: BO
authors.lastname: McElhanon
authors.forename: Bess T
authors.initials: BT
authors.lastname: Schoen
authors.forename: Gayathri
authors.initials: G
authors.lastname: Tenjarla
authors.forename: Courtney
authors.initials: C
authors.lastname: McCracken
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Ziegler
authors.forename: Vin
authors.initials: V
authors.lastname: Tangpricha
authors.forename: Subra
authors.initials: S
authors.lastname: Kugathasan
mesh_terms: D000293:Adolescent; D002118:Calcium / Q000097:blood; D002648:Child; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000097:blood / Q000150:complications*; D008297:Male; D010281:Parathyroid Hormone / Q000097:blood; D010372:Pediatrics; D010865:Pilot Projects; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D014815:Vitamins / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use
chemical_list: D010281:Parathyroid Hormone; D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D; D002118:Calcium