Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)
Vitamin D Supplementation in Polycystic Ovary Syndrome: a Randomized Controlled Trial.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Penn State College of Medicine, Penn State Milton S Hershey Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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Placebo by mouth once daily for 12 weeks
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实验性的：维生素D
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Vitamin D 300 mcg by mouth once daily for 12 weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)
大体时间：Baseline and 12 weeks
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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))]).
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Baseline and 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)
大体时间：Baseline and 12 weeks
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High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.
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Baseline and 12 weeks
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Change From Baseline in Mean Systolic Blood Pressure
大体时间：Baseline and 12 weeks
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Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
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Baseline and 12 weeks
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Change From Baseline in Mean Diastolic Blood Pressure
大体时间：Baseline and 12 weeks
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Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.
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Baseline and 12 weeks
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Change From Baseline in Mean Fasting Glucose
大体时间：Baseline and 12 weeks
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Glucose was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean Fasting Insulin
大体时间：Baseline and 12 weeks
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Insulin was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean 2-hour Glucose
大体时间：Baseline and 12 weeks
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Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).
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Baseline and 12 weeks
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Change From Baseline in Mean 2-hour Insulin
大体时间：Baseline and 12 weeks
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Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).
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Baseline and 12 weeks
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Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)
大体时间：Baseline and 12 weeks
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Participants underwent a 75-g oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 120 minutes and used to calculate the insulin sensitivity index (ISI0,120).
The ISI 0,120 = the glucose uptake rate divided by the mean plasma glucose divided by the log(mean serum insulin).
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Baseline and 12 weeks
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Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
大体时间：Baseline and 12 weeks
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a validated measure of insulin resistance based on fasting insulin and glucose.
HOMA-IR is calculated as the product of fasting glucose and insulin divided by 22.5.
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Baseline and 12 weeks
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Change From Baseline in Mean Total Cholesterol
大体时间：Baseline and 12 weeks
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Lipid profile was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean HDL Cholesterol
大体时间：Baseline and 12 weeks
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Lipid profile was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean LDL Cholesterol
大体时间：Baseline and 12 weeks
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Lipid profile was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean Triglycerides
大体时间：Baseline and 12 weeks
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Lipid profile was assessed after 12 hours of fasting.
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Baseline and 12 weeks
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Change From Baseline in Mean Total Testosterone
大体时间：Baseline and 12 weeks
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Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
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Baseline and 12 weeks
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Change From Baseline in Mean Free Testosterone
大体时间：Baseline and 12 weeks
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Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.
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Baseline and 12 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Mean 25-hydroxyvitamin D
大体时间：Baseline and 12 weeks
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Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.
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Baseline and 12 weeks
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Change From Baseline in Mean Vitamin D Binding Protein
大体时间：Baseline and 12 weeks
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Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.
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Baseline and 12 weeks
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Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH)
大体时间：Baseline and 12 weeks
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Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.
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Baseline and 12 weeks
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合作者和调查者
调查人员
- 首席研究员：Nazia Raja-Khan, M.D.、Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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