Association Between Vitamin D and the Development of Uterine Fibroids
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- volume of the total fibroids
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 inhibit the growth of uterine fibroids in reproductive stage women.
详细描述
180 patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml) and uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group A and control group B. 180 patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml) and uterine fibroids will be also randomly assigned in a ratio of 1:1 to two groups: intervention group C and control group D. The intervention group A will receive 1600 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. Patients will be followed up at the same time points for 24 months. The outcome measure is the growth 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
- 否
入选标准
- •Patients are willing to cooperate with the follow-up and sign informed consent;
- •Females aged 35-50 who are diagnosed as having uterine fibroids by transvaginal or abdominal ultrasonography;
- •The maximum average diameter of intramural myoma is ≤ 4cm，≥ 1cm; The amount of myoma is less than 4;
- •Serum 25-hydroxyvitamin D3 < 30 ng/ml, ≥ 12 ng/ml.
排除标准
- •Patients with heavy menstrual bleeding (>80.0 mL), menstrual disorders, pelvic discomfort, infertility, or other indications for operation;
- •Patients complicated with myoma degeneration and adenomyosis that were suspected or diagnosed by ultrasound or gynecologic examination;
- •Allergic to vitamin D3;
- •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;
- •Suspected or identified as other tumors of genital tract;
- •History of osteoporosis or vitamin D deficiency taking vitamin D supplements within previous one month;
- •History of autoimmune diseases, infectious diseases (tuberculosis, AIDS), autoimmune diseases, 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 D deficiency treatment group
patients with vitamin D deficiency (12 ng/ml ≤ serum 25-hydroxyvitamin D3 < 20 ng/ml)and uterine fibroids receive 1600 IU/day of vitamin D3 oral capsule for two years
干预措施: Vitamin D 3 (Drug)
vitamin D insufficiency treatment group
patients with vitamin D insufficiency (20 ng/ml ≤ serum 25-hydroxyvitamin D3 < 30 ng/ml) and uterine fibroids receive 800 IU/d of vitamin D3
干预措施: Vitamin D 3 (Drug)
结局指标
主要结局
volume of the total fibroids
时间窗: two years after treatment
percent change in volume of the largest fibroid compared to baseline in different groups
次要结局
- abnormal renal function(Two years after treatment)
- volume of the total fibroids(One year after treatment)
- percentage of subjects undergoing other medical or surgical treatment of uterine fibroids(two years after treatment)
- Hypercalcemia(Two years after treatment)
- abnormal liver function(Two years after treatment)
- urinary calculus(Two years after treatment)
- volume of the largest fibroid(two years after treatment)