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

This study has been completed.
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01417351
First received: August 12, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Dietary Supplement: 400 IU vitamin D3
Dietary Supplement: 2,000 IU Vitamin D3

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

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in T-cell cytokine expression [ Time Frame: 16-20 wks, 26-28 wks, and 36 wks gestation ] [ Designated as safety issue: No ]
    Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry.


Secondary Outcome Measures:
  • Change in Vitamin D status [ Time Frame: 16-20 wks, 26-28 wks, 36 wks gestation ] [ Designated as safety issue: No ]
    Serum 25-OH vitamin D and 1, 25 (OH)2 Vitamin D

  • Change in innate immune function [ Time Frame: 16-20 wks, 26-28 wks, 36 wks gestation ] [ Designated as safety issue: No ]
    Monocyte and NK cell cytokine expression and response to stimulation with Toll-like Receptor agonists.

  • Change in blood pressure [ Time Frame: 16-20 wks, 26-28 wks, 36 wks gestation ] [ Designated as safety issue: No ]
    Blood pressure will be measured using standard techniques.


Enrollment: 60
Study Start Date: August 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417351

Locations
United States, California
USDA-Western Human Nutrition Research Center
Davis, California, United States, 95616
UC Davis Medical Center Obstetrics & Gynecology
Sacramento, California, United States, 95817
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
University of California, Davis
Investigators
Study Director: Charles B Stephensen, PhD USDA, ARS, Western Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01417351     History of Changes
Other Study ID Numbers: 217516
Study First Received: August 12, 2011
Last Updated: July 22, 2013
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
pregnancy
immune function

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 29, 2014