Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in T-cell cytokine expression
研究概览
简要总结
Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis Medical Center are currently conducting a study on the effects of vitamin D supplementation during pregnancy on maternal health and immune function. The investigators believe that vitamin D supplementation at levels greater than the current recommendation is beneficial for maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due to an imbalance in immune function at the placenta. This randomized, double-blind study is designed to test this hypothesis. Pregnant women who participate in the study receive either 400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28 weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The investigators are also collecting data on clinical parameters, such as blood pressure and glucose tolerance.
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
- 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
- 是
入选标准
- •Pregnant women
- •Less than 20 weeks gestation
- •Over 18 years of age
- •Able to swallow nutritional supplements
排除标准
- •Use of medications known to affect vitamin D metabolism
- •Diagnosis of type 1 diabetes
- •History of thyroid, renal, or liver disease
- •Problems with digestion or absorption
结局指标
主要结局
Change in T-cell cytokine expression
时间窗: 16-20 wks, 26-28 wks, and 36 wks gestation
Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry.
次要结局
- Change in Vitamin D status(16-20 wks, 26-28 wks, 36 wks gestation)
- Change in innate immune function(16-20 wks, 26-28 wks, 36 wks gestation)
- Change in blood pressure(16-20 wks, 26-28 wks, 36 wks gestation)
