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

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: 400 IU vitamin D3; Dietary supplement: 2,000 IU Vitamin D3

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • USDA-Western Human Nutrition Research Center
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center Obstetrics & Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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.	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.
EXPERIMENTAL: 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.	Dietary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in blood pressure	Blood pressure will be measured using standard techniques.	16-20 wks, 26-28 wks, 36 wks gestation

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Collaborators: University of California, Davis
• Investigators: Study Director: Charles B Stephensen, PhD, USDA, ARS, Western Human Nutrition Research Center

Publications and helpful links

General Publications

• Zerofsky MS, Jacoby BN, Pedersen TL, Stephensen CB. Daily Cholecalciferol Supplementation during Pregnancy Alters Markers of Regulatory Immunity, Inflammation, and Clinical Outcomes in a Randomized Controlled Trial. J Nutr. 2016 Nov;146(11):2388-2397. doi: 10.3945/jn.116.231480. Epub 2016 Sep 21.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 15, 2011
• First Posted (ESTIMATE): August 16, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2013
• Last Update Submitted That Met QC Criteria: July 22, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: pregnancy; immune function
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 217516 (University of California, San Francisco)