Pilot Study Evaluating Efficacy of 2 Regimens for Hypovitaminosis D Repletion in Pediatric Inflammatory Bowel Disease

• Type of Material: Article
• Authors: Robert Z. Simek, Emory University; Jarod Prince, Emory University; Sana Syed, Emory University; Cary Sauer, Emory University; Bernadette Martineau, Childrens Healthcare Atlanta; Tatyana Hofmekler, Emory University; Alvin Freeman, Emory University; Archana Kumar, Emory University; Barbara McElhanon, Emory University; Bess Schoen, Emory University; Gayathri Tenjarla, Emory University; Courtney McCracken, Emory University; Thomas Ziegler, Emory University; Vin Tangpricha, Emory University; Subramaniam Kugathasan, Emory University
• Language: English
• Date: 2016-02-01
• Publisher: Lippincott, Williams & Wilkins
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2016 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
• Final Published Version (URL): http://dx.doi.org/10.1097/MPG.0000000000000915
• Title of Journal or Parent Work: Journal of Pediatric Gastroenterology and Nutrition
• ISSN: 0277-2116
• Volume: 62
• Issue: 2
• Start Page: 252
• End Page: 258
• Grant/Funding Information: This work was supported, in part, by grants from the National Institutes of Health: DK087694 (SK), K23 AR054334 (VT) and K24 DK096574 (TRZ).
• Keywords: ADOLESCENTS; children; D INSUFFICIENCY; D DEFICIENCY; Gastroenterology & Hepatology; CHILDREN; BONE-MINERAL DENSITY; Nutrition & Dietetics; ulcerative colitis; Pediatrics; OLDER-ADULTS; vitamin D; Life Sciences & Biomedicine; CLINICAL-TRIAL; Science & Technology; Crohn disease; 25-HYDROXYVITAMIN-D; VITAMIN-D STATUS; PARATHYROID-HORMONE
• Research Categories: Health Sciences, Epidemiology

Abstract

Objectives: 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.