Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vitamin D Deficiency
- Sponsor
- USDA, Western Human Nutrition Research Center
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in T-cell cytokine expression
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women
- •Less than 20 weeks gestation
- •Over 18 years of age
- •Able to swallow nutritional supplements
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in T-cell cytokine expression
Time Frame: 16-20 wks, 26-28 wks, and 36 wks gestation
Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry.
Secondary Outcomes
- 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)