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

This study is ongoing, but not recruiting participants.
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: February 7, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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.


Estimated Enrollment: 68
Study Start Date: August 2010
Estimated Study Completion Date: June 2013
Estimated 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
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: February 7, 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 May 16, 2013