Vitamin D supplementation for prevention of cancer: The D2d cancer outcomes (D2dCA) study.
Vitamin D supplementation for prevention of cancer: The D2d cancer outcomes (D2dCA) study.
复制标题
补充维生素 D 预防癌症：D2d 癌症结果 (D2dCA) 研究。
DOI：
10.1016/j.cct.2019.04.015
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发表时间：
2019
影响因子：
2.2
通讯作者：
D2dResearchGroup
中科院分区：
文献类型：
--
作者：
Chatterjee,Ranee;Erban,JohnK;Fuss,Paul;Dolor,Rowena;LeBlanc,Erin;Staten,Myrlene;Sheehan,Patricia;Pittas,Anastassios;D2dResearchGroup
来自机制研究的生物相容性证据和来自观察性研究的数据表明，维生素D可能与几种癌症的风险有关。然而，临床试验评估维生素D补充剂对癌症风险影响的证据有限。维生素D和2型糖尿病（D2 d）研究是一项多中心，随机，安慰剂对照的临床试验，旨在检查口服维生素D补充剂与超重成人糖尿病前期糖尿病之间的因果关系。D2 d研究提供了一个独特的机会来评估维生素D补充剂的效果，其剂量（4000 IU/天）高于其他临床试验中使用的癌症结果，在高于平均癌症风险的人群中。该文件规定：a）D2 d癌症结局次要研究（D2 dCA）中包括的D2 d人群的基线特征，以及与其他维生素D补充剂和癌症风险的大型试验的比较; B）描述试验期间收集的数据以及计划进行的统计分析，以测试4000 IU/天剂量的维生素D补充剂是否对总体癌症发病率有影响，某些类型癌症的发病率和癌前病变的发病率。D2 dCA的结果将有助于指导未来与维生素D和癌症风险相关的研究和临床建议。
Evidence on biological plausibility from mechanistic studies and data from observational studies suggest that vitamin D may be linked to risk of several types of cancer. However, evidence from clinical trials evaluating the effect of vitamin D supplementation on cancer risk is limited. The Vitamin D and Type 2 Diabetes (D2d) study is a multi-center, randomized, placebo-controlled clinical trial conducted to examine the causal relationship between oral vitamin D supplementation and development of diabetes among overweight adults with prediabetes. The D2d study provides a unique opportunity to assess the effect of vitamin D supplementation at a higher dose (4000 IU/day) than has been used in other clinical trials with cancer outcomes, in a population at higher than average risk for cancer. This paper provides: a) baseline characteristics of the D2d population included in the D2d cancer outcomes secondary study (D2dCA) and comparison to other large trials of vitamin D supplementation and cancer risk; b) description of data that are being collected during the trial and the planned statistical analyses to test whether vitamin D supplementation at a dose of 4000 IU/day has an effect on incident cancer overall, on incidence of certain types of cancer, and on incidence of precancerous lesions. Results of D2dCA will help guide future research and clinical recommendations related to vitamin D and cancer risk.