Association Between Vitamin D and the Risk of Uterine Fibroids
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,160
- 试验地点
- 1
- 主要终点
- Incidence rate of uterine fibroids in different groups
研究概览
简要总结
The aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could reduce the risk of uterine fibroids in reproductive stage women.
详细描述
A total of 1160 hypovitaminosis D patients (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml) without uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group and control group. The intervention group will receive 1600 IU/d of vitamin D3; the control group will receive regular follow-up. Patients will be followed up at the same time points for 24 months. The outcome measure is the incidence of uterine fibroids in different groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Volunteer to participate in the study with informed consent;
- •Females aged 35-50 who are confirmed with a normal, fibroid-free uterine structure, by means of transvaginal or abdominal ultrasonography;
- •Serum25-hydroxyvitamin D3 <20 ng/ml, ≥ 12ng/ml.
排除标准
- •Use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (GnRHa), or other medication which is likely to interfere with uterine fibroids within 3 months;
- •Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
- •Allergic to vitamin D3;
- •Suspected or identified as other tumors of genital tract;
- •History of hysterectomy or myomectomy;
- •History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;
- •History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
- •Alanine aminotransferase (ALT) or aspartate transaminase (AST) more than 3 times of the normal upper limit, total bilirubin (TBIL) more than 2 times of the normal upper limit;
- •Creatinine levels ≥ 1.4 mg/dL (123μmol/L) or creatinine clearance ≤ 50 ml/min;
- •History of malignant tumors;
- •Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
研究组 & 干预措施
Vitamin D3 Drops group
Patients in this group would take Vitamin D3 400 UNT Oral Capsule.
干预措施: Vitamin D3 400 UNT Oral Capsule (Drug)
结局指标
主要结局
Incidence rate of uterine fibroids in different groups
时间窗: two years after treatment
Incidence rate of uterine fibroids in different groups after two years treatment
次要结局
- abnormal renal function(Two years after treatment)
- Hypercalcemia(Two years after treatment)
- abnormal liver function(Two years after treatment)
- Incidence rate of uterine fibroids in different groups(One year after treatment)