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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: 2,000 IU Vitamin D3; Dietary Supplement: 400 IU vitamin D3

• 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

Arm && Interventions

Group	Intervention	Description
2,000 IU Vitamin D3	2,000 IU Vitamin D3	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.
400 IU Vitamin D3	400 IU vitamin D3	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.

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