Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function

Not Applicable

Completed

• Conditions: Vitamin D Deficiency

• Registration Number: NCT01417351
• Lead Sponsor: USDA, Western Human Nutrition Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-22
• Last Update Posted: 2013-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in T-cell cytokine expression	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 Outcome Measures

Name	Time	Method
Change in Vitamin D status	16-20 wks, 26-28 wks, 36 wks gestation	Serum 25-OH vitamin D and 1, 25 (OH)2 Vitamin D
Change in innate immune function	16-20 wks, 26-28 wks, 36 wks gestation	Monocyte and NK cell cytokine expression and response to stimulation with Toll-like Receptor agonists.
Change in blood pressure	16-20 wks, 26-28 wks, 36 wks gestation	Blood pressure will be measured using standard techniques.

Trial Locations

Locations (2)

USDA-Western Human Nutrition Research Center; 🇺🇸 Davis, California, United States

UC Davis Medical Center Obstetrics & Gynecology; 🇺🇸 Sacramento, California, United States