Simek Robert Z, Prince Jarod, Syed Sana, Sauer Cary G, Martineau Bernadette, Hofmekler Tanya, Freeman Alvin J, Kumar Archana, McElhanon Barbara O, Schoen Bess T, Tenjarla Gayathri, McCracken Courtney, Ziegler Thomas R, Tangpricha Vin, Kugathasan Subra
*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.
J Pediatr Gastroenterol Nutr. 2016 Feb;62(2):252-8. doi: 10.1097/MPG.0000000000000915.
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.
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.
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.
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.
维生素D对骨骼健康至关重要;维生素D缺乏症在儿童炎症性肠病(IBD)中很常见,但最佳的补充疗法尚未得到充分研究。我们旨在进行一项试点试验,比较两种每周给药的维生素D方案对儿童IBD中维生素D缺乏症的补充效果。
从我们的IBD诊所中识别出25-羟基维生素D(25[OH]D)浓度<30 ng/mL的受试者,随机分为每周口服10,000(n = 18)或5000(n = 14)IU维生素D3/10 kg体重,共6周。在基线、第8周和第12周测量血清25(OH)D、钙和甲状旁腺激素浓度。
在高剂量组中,血清25(OH)D从基线时的23.7±8.5 ng/mL增加到第8周时的49.2±13.6 ng/mL;P<0.001。在低剂量组中,血清25(OH)D从基线时的24.0±7.0 ng/mL增加到第8周时的41.5±9.6 ng/mL;P<0.001。在第12周时,高剂量和低剂量方案的血清25(OH)D浓度分别为35.1±8.4和30.8±4.2 ng/mL。研究期间平均血清钙和甲状旁腺激素浓度无显著变化。没有患者出现高钙血症,也没有发生严重不良事件。
两个治疗组在使儿童IBD中的维生素D营养正常化方面都是安全有效的。虽然两个给药组在第8周时都显著补充了25(OH)D浓度,但在12周的随访中这种效果消失了。初始补充后可能需要维持维生素D治疗以维持长期正常的维生素D状态。