Association between vitamin D and uterine fibroids:a study protocol of an open-label,randomised controlled trial

doi:10.26914/c.cnkihy.2018.030890

科研成果详情

题名	Association between vitamin D and uterine fibroids:a study protocol of an open-label,randomised controlled trial
作者	Bo Sheng ; Saisai Li ; Yizuo Song ; Yi Liu ; Chenchen Jiang ; Xueqiong Zhu
发表日期	2018-11-22
会议录名称	2018年浙江省妇科肿瘤学学术年会暨温台妇产科年会论文汇编影响因子和分区
语种	英语
原始文献类型	中国会议
摘要	Introduction Uterine fibroids are the most common pelvic benign tumor with no satisfactory long-term medical treatment.The pathogenesis of fibroids is still unclear.Recent studies have demonstrated that vitamin D significantly inhibited the growth of fibroids in vitro and in vivo animal models.Our previous study found that the serum25-hydroxyvitamin D3 of patients with leiomyoma was significantly lower than the others without uterine fibroids and low vitamin D status increased the risk of leiomyoma.A small-sample clinical trial also indicated that adequate vitamin D supplementation stabilized the growth of human uterine fibroids.Therefore,the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could reduce the risk of uterine fibroids and inhibit the growth of uterine fibroids in reproductive stage women.Methods and analysis The 2 years,open-label,randomised controlled trial comprises two parts,including part I and part II.The first part is about the association between vitamin D and the risk of UFs.The second is about the relationship between vitamin D and the development of UFs.In part Ⅰ,a total of 1160 hypovitaminosis D patients without UFs will be randomly assigned to two groups:intervention group and control group.The intervention group will receive 1600 IU/d of vitamin D3 for 2 years;the control group will be followed up at the same time points.The incidence of UFs will be employed to measure the outcome in different groups.In part B,180 patients with vitamin D deficiency and UFs will be randomly assigned to two groups:intervention group A and control group B.180 patients with vitamin D insufficiency and UFs will be also randomly assigned to two groups:intervention group C and control group D.The intervention group A will receive1600 IU/d of vitamin D3;the intervention group C will receive 800 IU/d of vitamin D3;the control group B and the control group D will receive regular follow-up at the same time points for 2 years.The outcome measure will be conducted using the growth of UFs in different groups.Ethics and dissemination This study has been approved by the institutional review board of the Second Affiliated Hospital of Wenzhou Medical University(No.LCKY2018-35).The results will be published in peer-reviewed journals and related websites.
页码	1
DOI	10.26914/c.cnkihy.2018.030890
收录类别	CNKI
引用统计
文献类型	会议论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/167834
专题	第二临床医学院，附属第二医院、育英儿童医院
作者单位	1.Department of Obstetrics and Gynecology 2.the Second Affiliated Hospital of Wenzhou Medical University
推荐引用方式 GB/T 7714	Bo Sheng,Saisai Li,Yizuo Song,et al. Association between vitamin D and uterine fibroids:a study protocol of an open-label,randomised controlled trial[C],2018:1.