The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D: A Randomized, Double-blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 主要终点
- Visual analog pain scale
研究概览
简要总结
The purpose of this study is to evaluate the effect of vitamin D supplementation on the pain score of primary dysmenorrhea. Our hypothesis is that by normalizing vitamin D level could help improve pain score of women who have primary dysmenorrhea.
详细描述
This study is aimed to be conducted in randomised controlled trial, comparing between intervention group and placebo group. We include women with primary dysmenorrhea who also have low vitamin D level in this trial. Our primary outcome is to compare visual analog pain scale between intervention and placebo group after treatment. After randomised and allocated, these women will be given vitamin D 50,000 IU or placebo capsules orally weekly for 8 consecutive weeks. We monitor pain score daily from the cycle before the drugs started until complete 8-week course of the regimen mentioned. Also vitamin D levels will be monitored twice, one before treatment and the other after treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primary dysmenorrhea
- •Hypovitaminosis D
排除标准
- •Using calcium, magnesium or phosphorus in the past 3 months
- •Using hormonal contraception or IUD in the past 6 months
- •No smoking or alcohol drinking
- •Chronic underlying diseases
- •Allergic to components in study drugs
研究组 & 干预措施
Vitamin D
Vitamin D 50,000 IU orally weekly for 8 weeks
干预措施: Ergocalciferol Capsules (Drug)
Placebo
Placebo capsules orally weekly for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Visual analog pain scale
时间窗: 8 weeks
Pain score between intervention and placebo group after treatment
次要结局
未报告次要终点
研究者
Preeyaporn Jirakittidul
Doctor
Mahidol University