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临床试验/NCT01417351
NCT01417351已完成不适用

Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial

USDA, Western Human Nutrition Research Center4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年8月1日最近更新:
适应症

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

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)

研究者

发起方
USDA, Western Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (4)

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