Effect of Vitamin D3 and Omega-3FA on Estradiol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 主要终点
- Plasma concentrations of 25-hydroxyvitamin D, estradiol
研究概览
简要总结
The effect of vitamin D3 and omega-3 Fatty acids on estradiol levels.
详细描述
The data about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum levels of estradiol (E2) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the E2 levels.
This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum E2 levels in premenopausal females with vitamin D deficiency (VDD).
This randomized, placebo-controlled clinical trial was designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on the mid-follicular serum levels of E2 and 25-hydroxy vitamin D (25OHD). This study was conducted during winter in 86 healthy premenopausal Jordanian females with VDD with a mean age of (32.8 ± 8.9) years. Fasting serum levels for 25OHD, E2, PTH (parathyroid hormon), calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal females
- •Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml)
排除标准
- •Women previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation. Women who are pregnant, breastfeeding or using hormonal contraceptives were also excluded.
结局指标
主要结局
Plasma concentrations of 25-hydroxyvitamin D, estradiol
时间窗: 8 weeks
Concentration
次要结局
- Plasma concentrations of PTH, Ca(8 weeks)