背景。由于紫外线照射不足,建议摄入少量维生素D以预防肌肉骨骼疾病。基础科学和观察文献都强烈表明,较高的剂量可能使特定人群受益,并且具有非肌肉骨骼作用。鉴于相对较大且不断增长的临床试验证据跨越时间,评估围绕高剂量补充的证据可能具有挑战性。地理,人群和给药方案。研究目标是确定和总结临床试验文献,识别具有高质量证据的领域,并开发一个资源数据库,使最终用户更容易访问文献。方法。Medline(1946年至2015年1月),Embase(1974年至2015年1月),和Cochrane数据库(2015年1月),正在寻找试验。所有儿科(0-18年)试验给予剂量高于400IU(<1年)或600IU(≥1年)包括在内。数据由两位作者独立提取。开发了一个可在线搜索的试验数据库,其中包含相关的提取信息(http://www。cheori.org/en/pedvitaminddatabaseOverview)。通过将数据库中的试验与包括儿童在内的补充维生素D的系统评价进行比较来评估敏感性和实用性。结果。共确定了2579篇候选论文,产生169项试验,其中一项或多项武器符合资格标准.出版率从每年1(1970-1979)大幅增加到每年14(2010-2015)。尽管84%的试验集中在健康儿童或已知的高危人群(例如,肾,早产),近年来,这一比例有所下降,原因是评价与维生素D的肌肉骨骼活动无直接关系的人群和结局的试验增加(2010年为27%).除了健康的孩子,在评估临床相关结局的低偏倚风险试验中,仅有超过50名参与者的儿科人群是早产和呼吸系统疾病.最后,我们使用最近的13篇系统综述创建并验证了可在线搜索的数据库.在系统评价确定的38项高剂量试验中,36(94.7%)可以在数据库中找到。与每次系统评价中报告的搜索策略相比,数据库的使用使评估合格性的完整论文数量减少了85.2%(±13.4%).结论。儿科维生素D领域非常活跃,评估非经典疾病和结局的试验显着增加。尽管总体数量很大,但很少有足够规模的高质量试验来提供关于高剂量维生素D临床疗效的答案。开放获取的在线可搜索数据应有助于最终用户快速,全面地识别和评估与他们的人群或感兴趣的问题相关的试验。
Background. Due to inadequate UV exposure, intake of small quantities of vitamin D is recommended to prevent musculoskeletal disease. Both basic science and observational literature strongly suggest that higher doses may benefit specific populations and have non-musculoskeletal roles. Evaluating the evidence surrounding high dose supplementation can be challenging given a relatively large and growing body of clinical trial evidence spanning time, geography, populations and dosing regimens. Study objectives were to identify and summarize the clinical trial literature, recognize areas with high quality evidence, and develop a resource database that makes the literature more immediately accessible to end users. Methods. Medline (1946 to January 2015), Embase (1974 to January 2015), and Cochrane databases (January 2015), were searched for trials. All pediatric (0-18 years) trials administering doses higher than 400 IU (<1 year) or 600 IU (≥1 year) were included. Data was extracted independently by two of the authors. An online searchable database of trials was developed containing relevant extracted information (http://www.cheori.org/en/pedvitaminddatabaseOverview). Sensitivity and utility were assessed by comparing the trials in the database with those from systematic reviews of vitamin D supplementation including children. Results. A total of 2,579 candidate papers were identified, yielding 169 trials having one or more arms meeting eligibility criteria. The publication rate has increased significantly from 1 per year (1970-1979) to 14 per year (2010-2015). Although 84% of the total trials focused on healthy children or known high risk populations (e.g., renal, prematurity), this proportion has declined in recent years due to the rise in trials evaluating populations and outcomes not directly related to the musculoskeletal actions of vitamin D (27% in 2010s). Beyond healthy children, the only pediatric populations with more than 50 participants from low risk of bias trials evaluating a clinically relevant outcome were prematurity and respiratory illness. Finally, we created and validated the online searchable database using 13 recent systematic reviews. Of the 38 high dose trials identified by the systematic
review, 36 (94.7%) could be found within the database. When compared with the search strategy reported in each systematic
review, use of the database reduced the number of full papers to assess for eligibility by 85.2% (±13.4%). Conclusion. The pediatric vitamin D field is highly active, with a significant increase in trials evaluating non-classical diseases and outcomes. Despite the large overall number there are few high quality trials of sufficient size to provide answers on clinical efficacy of high-dose vitamin D. An open access online searchable data should assist end users in the rapid and comprehensive identification and evaluation of trials relevant to their population or question of interest.