Pappa Helen M, Mitchell Paul D, Jiang Hongyu, Kassiff Sivan, Filip-Dhima Rajna, DiFabio Diane, Quinn Nicolle, Lawton Rachel C, Bronzwaer M E S, Koenen Mirjam, Gordon Catherine M
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.
J Clin Endocrinol Metab. 2014 Sep;99(9):3408-17. doi: 10.1210/jc.2013-4218. Epub 2014 Jun 13.
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.
The objective of the study was to compare two supplementation regimens' efficacy and safety in maintaining optimal 25OHD in children with IBD.
This was a randomized, not blinded, controlled trial.
The trial was conducted in the Boston Children's Hospital Clinical and Translational Study Unit.
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.
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).
The main outcome was the probability of maintaining 25OHD of 32 ng/mL or greater in all trimonthly visits for 12 months.
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).
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.
维生素D可促进骨骼健康并调节免疫系统，这对患有炎症性肠病（IBD）的儿科患者来说都是重要的作用。维持最佳血清25-羟基维生素D浓度（25OHD≥32 ng/mL）所需的补充剂量尚不清楚。
本研究的目的是比较两种补充方案在维持IBD患儿最佳25OHD水平方面的疗效和安全性。
这是一项随机、非盲法对照试验。
该试验在波士顿儿童医院临床与转化研究单元进行。
招募了63名年龄在8至18岁之间、患有IBD且基线25OHD大于20 ng/mL的患者；48名完成了研究，1名因不良事件退出。
A组每天口服400 IU维生素D2（n = 32）。B组在夏季/秋季每天服用1000 IU，冬季/春季每天服用2000 IU（n = 31）。
主要结局是在12个月的所有季度访视中维持25OHD水平在32 ng/mL或更高的概率。
A组有3名参与者（9.4%），B组有3名参与者（9.7%）达到了主要结局（P = 0.97）。不良事件的发生率均较低，无差异。A组有更多参与者的C反应蛋白水平达到或高于1 mg/dL（31%对10%，P = 0.04），白细胞介素-6水平高于3 pg/mL（54%对27%，P = 0.05）。
每日口服高达2000 IU的维生素D2不足以维持最佳25OHD水平，但耐受性良好。在接受较高剂量维生素D2的参与者中炎症标志物和细胞因子升高的发生率较低这一发现值得进一步研究。
