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Clinical Trials/NCT01417351
NCT01417351
Completed
Not Applicable

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 Center2 sites in 1 country60 target enrollmentAugust 2010

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
USDA, Western Human Nutrition Research Center
Responsible Party
Sponsor

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)

Study Sites (2)

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