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NCT Number: NCT01417351

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

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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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

400 IU vitamin D3

Dietary Supplement

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.

2,000 IU Vitamin D3

Dietary 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.

Primary outcomes

  1. 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

  1. Change in Vitamin D status

    Time frame: 16-20 wks, 26-28 wks, 36 wks gestation

    Serum 25-OH vitamin D and 1, 25 (OH)2 Vitamin D

  2. Change in innate immune function

    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.

  3. Change in blood pressure

    Time frame: 16-20 wks, 26-28 wks, 36 wks gestation

    Blood pressure will be measured using standard techniques.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • University of California, Davis

Registry information

Official study title

Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2011
Registry last updated
Jul 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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