Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function
Completed · Not applicable · Has a placebo group
Conditions studied: Vitamin D Deficiency
In brief
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.
Key facts
- Study ID
- NCT01417351
- Run by
- USDA, Western Human Nutrition Research Center
- People needed
- 60
- Starts
- 2010-08-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2013-07-23
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant women
- Less than 20 weeks gestation
- Over 18 years of age
- Able to swallow nutritional supplements
You may not qualify if…
- 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
Where it is running
- USDA-Western Human Nutrition Research Center — Davis, California, United States
- UC Davis Medical Center Obstetrics & Gynecology — Sacramento, California, United States
Full record on ClinicalTrials.gov
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