Vitamin D in the Treatment of Primary Dysmenorrhoea: A Prospective Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 主要终点
- pain score ,make a mark on a 10-cm visual analog scale (VAS)
研究概览
简要总结
Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial. Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400 mg ibuprofen twice a day,2 days before the date of menstruation and continued through the first 3 days, for 2 months. Main outcome measures: Pain score. Results: Mean VAS of vitamin D group was 4,91, was 6,54 in the vitamin E group and was 4,02 in the ibuprofen group Conclusion:Vitamin D and vitamin E are effective in relieving the pain,but the effect of vitamin D are more prominent
详细描述
An excessive uterine production of prostaglandins is the pathogenic trigger of dysmenorrhoea. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the currently accepted drugs for the management of this disorder. The capacity for synthesizing vitamin D and the presence of vitamin D receptor in human cycling endometrium have also been demonstrated. Because vitamin D reduces the synthesis of prostaglandins, a beneficial effect of vitamin D for the uterus is possible.Vitamin E inhibits the release of arachidonic acid and the conversion of arachidonic acid to prostaglandin via an action on the enzymes phospholipase A2 and cyclooxygenase.
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
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women had regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 7 days;
- •Women had to be in good health and taking no medications including calcium, magnesium, vitamin D and oral contraceptives.
- •Women had not a previous history of gynaecological disease, and a normal pelvic examination were eligible.
排除标准
- •Previous and current use of intrauterine contraceptive devices within the 6 months to enrollment was not permitted
研究组 & 干预措施
vitamin D
667 unit of vitamin D once a day ,two days before the expected date of menstruation and continued through the first three days of bleeding.
干预措施: Vitamin D (Dietary Supplement)
vitamin E
200 unit of vitamin E once a day ,two days before the expected date of menstruation and continued through the first three days of bleeding.
干预措施: Vitamin E (Dietary Supplement)
ibuprofen
400 mg ibuprofen twice a day, two days before the expected date of menstruation and continued through the first three days of bleeding.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
pain score ,make a mark on a 10-cm visual analog scale (VAS)
时间窗: 2 months
次要结局
未报告次要终点
研究者
Aysegül Özel
Medical Doctor
Bezmialem Vakif University