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

Vitamin D Deficiency Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417351
• Other study ID #: 217516
• Status: Completed
• Phase: N/A
• First received: August 12, 2011
• Last updated: July 22, 2013
• Start date: August 2010
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• 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.
• 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.

Locations

Country	Name	City	State
United States	USDA-Western Human Nutrition Research Center	Davis	California
United States	UC Davis Medical Center Obstetrics & Gynecology	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in T-cell cytokine expression	Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry.	16-20 wks, 26-28 wks, and 36 wks gestation	No
Secondary	Change in Vitamin D status	Serum 25-OH vitamin D and 1, 25 (OH)2 Vitamin D	16-20 wks, 26-28 wks, 36 wks gestation	No
Secondary	Change in innate immune function	Monocyte and NK cell cytokine expression and response to stimulation with Toll-like Receptor agonists.	16-20 wks, 26-28 wks, 36 wks gestation	No
Secondary	Change in blood pressure	Blood pressure will be measured using standard techniques.	16-20 wks, 26-28 wks, 36 wks gestation	No