400 IU vitamin D3
Dietary SupplementWomen in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement.
NCT Number: NCT01417351
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
USDA-Western Human Nutrition Research Center, Davis, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement.
Women in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement.
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.
Time frame: 16-20 wks, 26-28 wks, 36 wks gestation
Serum 25-OH vitamin D and 1, 25 (OH)2 Vitamin D
Time frame: 16-20 wks, 26-28 wks, 36 wks gestation
Monocyte and NK cell cytokine expression and response to stimulation with Toll-like Receptor agonists.
Time frame: 16-20 wks, 26-28 wks, 36 wks gestation
Blood pressure will be measured using standard techniques.
USDA, Western Human Nutrition Research Center
Fed
Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial
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