NCT03991078已完成不适用
Pilot Clinical Study to Evaluate the Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency
Fundación IVI1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年7月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- volume of the uterine fibroids
研究概览
简要总结
Vitamin D supplementation in patients with uterine fibroids who present hypovitaminosis D to re-establish their normal serum values could stabilize the size of the uterine fibroids and thus prevent their growth or reduce their size thanks to the anti-proliferative action of Vitamin D on the myoma cells.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with at least one fibroid > 3 cm
- •With hypovitaminosis D (25(OH)D < 30 ng/ml)
- •BMI < 30
- •No hormonal treatment in the 3 months prior to the ultrasound study
排除标准
- •Black race
- •Symptomatic fibroids subsidiary to hormonal or surgical treatment
- •Desire of gestation in the next 6 months
- •Presence of degenerating adenomyosis or fibroids
- •Treatment with sexual hormones: mifepristone, aGnRH or any other medication that may interfere with fibroids.
- •History of neoplasia of gynecological origin and/or existence of uterine malformations.
- •Hypercalcemia or abnormal liver or kidney function is present
结局指标
主要结局
volume of the uterine fibroids
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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