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J. Clin. Endocrinol. Metab. · Jun 2012
Randomized Controlled Trial Comparative StudyTreatment of vitamin D insufficiency in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing three regimens.
- Helen M Pappa, Paul D Mitchell, Hongyu Jiang, Sivan Kassiff, Rajna Filip-Dhima, Diane DiFabio, Nicolle Quinn, Rachel C Lawton, Mark Varvaris, Stephanie Van Straaten, and Catherine M Gordon.
- Division of Gastroenterology and Nutrition, Children's Hospital Boston, Boston, Massachusetts 02115, USDA . Helen.pappa@childrens.harvard.edu
- J. Clin. Endocrinol. Metab. 2012 Jun 1; 97 (6): 2134-42.
ContextVitamin D insufficiency [serum 25-hydroxyvitamin D (25OHD) concentration less than 20 ng/ml] is prevalent among children with inflammatory bowel disease (IBD), and its treatment has not been studied.ObjectiveThe aim of this study was to compare the efficacy and safety of three vitamin D repletion regimens.Design And SettingWe conducted a randomized, controlled clinical trial from November 2007 to June 2010 at the Clinical and Translational Study Unit of Children's Hospital Boston. The study was not blinded to participants and investigators.PatientsEligibility criteria included diagnosis of IBD, age 5-21, and serum 25OHD concentration below 20 ng/ml. Seventy-one patients enrolled, 61 completed the trial, and two withdrew due to adverse events.InterventionPatients received orally for 6 wk: vitamin D(2), 2,000 IU daily (arm A, control); vitamin D(3), 2,000 IU daily (arm B); vitamin D(2), 50,000 IU weekly (arm C); and an age-appropriate calcium supplement.Main Outcome MeasureWe measured the change in serum 25OHD concentration (Δ25OHD) (ng/ml). Secondary outcomes included change in serum intact PTH concentration (ΔPTH) (pg/ml) and the adverse event occurrence rate.ResultsAfter 6 wk, Δ25OHD ± se was: 9.3 ± 1.8 (arm A); 16.4 ± 2.0 (arm B); 25.4 ± 2.5 (arm C); P (A vs. C) = 0.0004; P (A vs. B) = 0.03. ΔPTH ± SE was -5.6 ± 5.5 (arm A); -0.1 ± 4.2 (arm B); -4.4 ± 3.9 (arm C); P = 0.57. No participant experienced hypercalcemia or hyperphosphatemia, and the prevalence of hypercalciuria did not differ among arms at follow-up.ConclusionsOral doses of 2,000 IU vitamin D(3) daily and 50,000 IU vitamin D(2) weekly for 6 wk are superior to 2,000 IU vitamin D(2) daily for 6 wk in raising serum 25OHD concentration and are well-tolerated among children and adolescents with IBD. The change in serum PTH concentration did not differ among arms.
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