Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
研究概览
简要总结
The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.
详细描述
As many cells throughout the body possess the vitamin D receptor, adequate vitamin D levels may be essential for multiple physiologic functions. In recent years, vitamin D insufficiency has been linked to insulin resistance, inflammation, poor psychological health, obesity, type 2 diabetes, and cardiovascular disease - these are also commonly found in women with Polycystic Ovary syndrome (PCOS). We believe that vitamin D insufficiency contributes to insulin resistance, inflammation, and psychological distress in women with PCOS. These adverse effects may ultimately increase the risk for serious long-term complications in PCOS, including type 2 diabetes and cardiovascular disease. The key objectives of this research study are to determine the effects of vitamin D supplementation on insulin resistance, inflammation, mood and overall well-being in women with PCOS.
The protocol has been modified by adding the following specific aim: To compare vascular function in healthy age and BMI similar matched women to PCOS women pre-treatment. Our hypothesis is that PCOS women will have greater attenuations in retinal vascular reactivity compared to healthy control women, demonstrating poorer endothelial function. We are currently recruiting healthy women who are age and BMI similar to the PCOS women and measure their retinal vascular reactivity for comparisons to the PCOS women's pre-treatment vascular reactivity. These healthy women will only have a baseline visit in which retinal vascular reactivity will be measured. They will not be enrolled in the placebo or Vitamin D randomization process as described above.
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
- Double (Participant, Investigator)
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
- •Diagnosis of PCOS based on:
- •Eight or fewer menstrual periods per year or spontaneous intermenstrual periods of greater than or equal to 45 days, and
- •Elevated testosterone levels
排除标准
- •Current Pregnancy or Nursing
- •Elevated calcium
- •Kidney Stones or kidney disease
- •Current use of vitamin D (other than a multivitamin)
- •Use of metformin or other insulin sensitizing drugs in the last 3 months
- •Elevated prolactin or untreated thyroid disease
- •Diabetes, Liver disease, Heart disease, or other serious medical condition
研究组 & 干预措施
Vitamin D
干预措施: Vitamin D (Dietary Supplement)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
时间窗: Baseline and 12 weeks
Quantitative insulin sensitivity check index (QUICKI) is a validated measure of insulin sensitivity based on fasting insulin and glucose. Quantitative insulin sensitivity check index (QUICKI) = 1/\[log(I(0)) + log(G(0))\]).
次要结局
- Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)(Baseline and 12 weeks)
- Change From Baseline in Mean Systolic Blood Pressure(Baseline and 12 weeks)
- Change From Baseline in Mean Diastolic Blood Pressure(Baseline and 12 weeks)
- Change From Baseline in Mean Fasting Glucose(Baseline and 12 weeks)
- Change From Baseline in Mean Fasting Insulin(Baseline and 12 weeks)
- Change From Baseline in Mean 2-hour Glucose(Baseline and 12 weeks)
- Change From Baseline in Mean 2-hour Insulin(Baseline and 12 weeks)
- Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)(Baseline and 12 weeks)
- Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Baseline and 12 weeks)
- Change From Baseline in Mean Total Cholesterol(Baseline and 12 weeks)
- Change From Baseline in Mean HDL Cholesterol(Baseline and 12 weeks)
- Change From Baseline in Mean LDL Cholesterol(Baseline and 12 weeks)
- Change From Baseline in Mean Triglycerides(Baseline and 12 weeks)
- Change From Baseline in Mean Total Testosterone(Baseline and 12 weeks)
- Change From Baseline in Mean Free Testosterone(Baseline and 12 weeks)
研究者
Nazia Raja-Khan
M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism
Milton S. Hershey Medical Center