title: Maintenance of optimal vitamin D status in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing two regimens.
abstract: BACKGROUND
  Vitamin D promotes bone health and regulates the immune system, both important actions for pediatric patients with inflammatory bowel disease (IBD). The supplementation dose that would maintain optimal serum 25-hydroxyvitamin D concentration (25OHD ≥ 32 ng/mL) is unknown.
  
  
  OBJECTIVE
  The objective of the study was to compare two supplementation regimens' efficacy and safety in maintaining optimal 25OHD in children with IBD.
  
  
  METHODS
  This was a randomized, not blinded, controlled trial.
  
  
  METHODS
  The trial was conducted in the Boston Children's Hospital Clinical and Translational Study Unit.
  
  
  METHODS
  Sixty-three patients, aged 8-18 years with IBD and baseline 25OHD greater than 20 ng/mL were enrolled; 48 completed the study, and one withdrew for adverse events.
  
  
  METHODS
  Arm A received 400 IU of oral vitamin D2 daily (n = 32). Arm B received 1000 IU daily in the summer/fall and 2000 IU in the winter/spring (n = 31).
  
  
  RESULTS
  The main outcome was the probability of maintaining 25OHD of 32 ng/mL or greater in all trimonthly visits for 12 months.
  
  
  RESULTS
  Three participants in arm A (9.4%) and three in arm B (9.7%) achieved the primary outcome (P = .97). The incidence of adverse events, all minor, did not differ. More participants in arm A developed C-reactive protein level of 1 mg/dL or greater (31% vs 10%, P = .04) and IL-6 greater than 3 pg/mL (54% vs 27%, P = .05).
  
  
  CONCLUSIONS
  Daily oral vitamin D2 doses up to 2000 IU were inadequate to maintain optimal 25OHD but were well tolerated. The finding of lower incidence of elevated inflammatory markers and cytokines among participants receiving higher vitamin D2 doses merits further study.
authors.affiliation: Center for Inflammatory Bowel Diseases (H.M.P., S.K.), Clinical Research Center Design and Analysis Core (P.D.M., H.J., R.F.-D.), and Clinical and Translational Study Unit (D.D., N.Q.), Children's Hospital Boston, Boston, Massachusetts 02115; Center for Psychosocial Research in GI, Northwestern University Feinberg School of Medicine (R.C.L.), Chicago, Illinois 60611; Academic Medical Center (M.E.S.B., M.K.), 1105 AZ Amsterdam, The Netherlands; and Divisions of Adolescent Medicine and Endocrinology, Hasbro Children's Hospital and Alpert Medical School of Brown University (C.M.G.), Providence, Rhode Island 02903.
authors.forename: Helen M
authors.initials: HM
authors.lastname: Pappa
authors.forename: Paul D
authors.initials: PD
authors.lastname: Mitchell
authors.forename: Hongyu
authors.initials: H
authors.lastname: Jiang
authors.forename: Sivan
authors.initials: S
authors.lastname: Kassiff
authors.forename: Rajna
authors.initials: R
authors.lastname: Filip-Dhima
authors.forename: Diane
authors.initials: D
authors.lastname: DiFabio
authors.forename: Nicolle
authors.initials: N
authors.lastname: Quinn
authors.forename: Rachel C
authors.initials: RC
authors.lastname: Lawton
authors.forename: M E S
authors.initials: ME
authors.lastname: Bronzwaer
authors.forename: Mirjam
authors.initials: M
authors.lastname: Koenen
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Gordon
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000378:metabolism; D003424:Crohn Disease / Q000188:drug therapy* / Q000378:metabolism; D019587:Dietary Supplements; D004872:Ergocalciferols / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014466:Ultraviolet Rays; D014807:Vitamin D / Q000031:analogs & derivatives* / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000188:drug therapy*; D014815:Vitamins / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D004872:Ergocalciferols; D014815:Vitamins; D014807:Vitamin D; C104450:25-hydroxyvitamin D